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HomeSearchRxCUI 198243: Brands

NDC properties for "temazepam 7.5 MG Oral Capsule" (RxCUI 198243)

About this data

The tables show NDC propoerties for temazepam 7.5 MG Oral Capsule with the RxCUI 198243

This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product

Details for temazepam 7.5 MG Oral Capsule (RxCUI 198243)

ANDAANDA070920
ANDAANDA071457
ANDAANDA078581
ANDAANDA201781
ANDAANDA203482
ANDAANDA211542
MMSL_CODEBD3274
MMSL_CODECD3274
NDANDA018163
RxCUI198243
SNOMEDCT371376001
SPL_SET_ID147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9
SPL_SET_ID23ff2d2f-4770-4760-9b41-a850329bb2c7
SPL_SET_ID2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d
SPL_SET_ID3ce42f0e-821e-4c9a-8f6b-60621628fd4b
SPL_SET_ID405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1
SPL_SET_ID4ac590e9-af71-43c0-a836-b700115d7ba2
SPL_SET_ID6559dfee-c29b-4707-8b30-8ca14bf23ea0
SPL_SET_ID85327378-86a3-4448-9185-e20bb20ebf45
SPL_SET_ID8f54731f-c5b7-492c-acb0-444c5fbb7029
SPL_SET_ID93b1be7f-ec41-46bb-a258-56cb459e2c92
SPL_SET_IDa3f06243-fa03-4cbd-951a-144ec43dcdfd
SPL_SET_IDaeaa1606-a75f-44ad-99de-56567fcc40dc
SPL_SET_IDbe68c6e0-17ad-40fe-9bc1-58abe24b53f6
SPL_SET_IDc9bc61b4-a579-4003-98da-b6f6e381c150
SPL_SET_IDd4a241c7-a4de-4f6b-b831-e063cf8c3d54
SPL_SET_IDdb839409-8e95-41d3-804e-dcd5d11f4934
VUID4002700
Prescribable Synonymtemazepam 7.5 MG Oral Capsule
RXNAV_STRtemazepam 7.5 MG Oral Capsule
RxNorm Nametemazepam 7.5 MG Oral Capsule
Related queriesInteractions (for RxCUI 198243)



NDC Properties

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
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NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0406-9960

NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 43547-611

NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826

NDC Item 00378311001

NDC 90378-3110
NDC 100378-3110-01
NDC Item00378311001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3110
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-05-18
Marketing statusCOMPLETED
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-3110

NDC Item 00406996001

NDC 90406-9960
NDC 100406-9960-01
NDC Item00406996001
Packaging100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerSpecGx LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 00904643604

NDC 90904-6436
NDC 100904-6436-04
NDC Item00904643604
Packaging30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 0904-6436

NDC Item 00904643660

NDC 90904-6436
NDC 100904-6436-60
NDC Item00904643660
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id865031
Imprint code7;5mg;Novel120
LabelerMajor Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43353015230

NDC 943353-152
NDC 1043353-152-30
NDC Item43353015230
Packaging30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015253

NDC 943353-152
NDC 1043353-152-53
NDC Item43353015253
Packaging60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353015260

NDC 943353-152
NDC 1043353-152-60
NDC Item43353015260
Packaging90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDAANDA071457
COLORTEXTWHITE(opaque body),PINK(opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id274934
Imprint code7;5;mg;Novel;120
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-03-25
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43353-152

NDC Item 43353071130

NDC 943353-711
NDC 1043353-711-30
NDC Item43353071130
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071153

NDC 943353-711
NDC 1043353-711-53
NDC Item43353071153
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43353071160

NDC 943353-711
NDC 1043353-711-60
NDC Item43353071160
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDAANDA070920
COLORTEXTORANGE(peach opaque),WHITE(ivory opaque)
ColorC48331;C48325 __
DCSACIV
FDA SPL set id123301
Imprint codeMYLAN;3110
LabelerAphena Pharma Solutions - Tennessee, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-10-25
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43353-711

NDC Item 43547061110

NDC 943547-611
NDC 1043547-611-10
NDC Item43547061110
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDAANDA201781
COLORTEXTBLUE(blue opaque/pink opaque)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code7;5mg;S611
LabelerSolco Healthcare U.S., LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-01-05
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 46708037930

NDC 946708-379
NDC 1046708-379-30
NDC Item46708037930
Packaging30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 46708037931

NDC 946708-379
NDC 1046708-379-31
NDC Item46708037931
Packaging100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA222
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 46708-379

NDC Item 53489064801

NDC 953489-648
NDC 1053489-648-01
NDC Item53489064801
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDAANDA078581
COLORTEXTwhite(opaque),turquoise(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;866
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-648

NDC Item 62332037930

NDC 962332-379
NDC 1062332-379-30
NDC Item62332037930
Packaging30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 62332037931

NDC 962332-379
NDC 1062332-379-31
NDC Item62332037931
Packaging100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque pink body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA222
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 62332-379

NDC Item 63187071815

NDC 963187-718
NDC 1063187-718-15
NDC Item63187071815
Packaging15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071820

NDC 963187-718
NDC 1063187-718-20
NDC Item63187071820
Packaging20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071830

NDC 963187-718
NDC 1063187-718-30
NDC Item63187071830
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071860

NDC 963187-718
NDC 1063187-718-60
NDC Item63187071860
Packaging60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63187071890

NDC 963187-718
NDC 1063187-718-90
NDC Item63187071890
Packaging90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDAANDA078581
COLORTEXTWHITE(opaque),TURQUOISE(opaque)
ColorC48325;C48334 __
DCSACIV
FDA SPL set id425784
Imprint codeMutual;866
LabelerProficient Rx LP
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-09-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63187-718

NDC Item 63629860101

NDC 963629-8601
NDC 1063629-8601-1
NDC Item63629860101
Packaging100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id801649
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63629-8601

NDC Item 63739000333

NDC 963739-003
NDC 1063739-003-33
NDC Item63739000333
Packaging3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDAANDA071457
COLORTEXTwhite(white opaque body),pink(pink opaque cap)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id853339
Imprint code7;5mg;Novel120
LabelerMcKesson Corporation dba SKY Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2025-10-31
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 63739-003

NDC Item 65162058303

NDC 965162-583
NDC 1065162-583-03
NDC Item65162058303
Packaging30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058310

NDC 965162-583
NDC 1065162-583-10
NDC Item65162058310
Packaging100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058311

NDC 965162-583
NDC 1065162-583-11
NDC Item65162058311
Packaging1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 65162058350

NDC 965162-583
NDC 1065162-583-50
NDC Item65162058350
Packaging500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),blue(OPAQUE CAP)
ColorC48325;C48333 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;583
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2016-05-23
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 65162-583

NDC Item 67877014801

NDC 967877-148
NDC 1067877-148-01
NDC Item67877014801
Packaging100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 67877014805

NDC 967877-148
NDC 1067877-148-05
NDC Item67877014805
Packaging500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 67877014830

NDC 967877-148
NDC 1067877-148-30
NDC Item67877014830
Packaging30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code7;5mg;Novel120
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 67877-148

NDC Item 68084054911

NDC 968084-549
NDC 1068084-549-11
NDC Item68084054911
Packaging1 in 1 BLISTER PACK
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 68084054921

NDC 968084-549
NDC 1068084-549-21
NDC Item68084054921
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXTpink,blue
ColorC48328;C48333 __
DCSACIV
FDA SPL set id767934
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2012-08-01
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 68084-549

NDC Item 71610000430

NDC 971610-004
NDC 1071610-004-30
NDC Item71610000430
Packaging30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000453

NDC 971610-004
NDC 1071610-004-53
NDC Item71610000453
Packaging60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71610-004

NDC Item 71610000460

NDC 971610-004
NDC 1071610-004-60
NDC Item71610000460
Packaging90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXTPINK,BLUE
ColorC48328;C48333 __
DCSACIV
FDA SPL set id382465
Imprint codeFOR;SLEEP;M;7;5;mg
LabelerAphena Pharma Solutions - Tennessee, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2010-02-23
Marketing statusACTIVE
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182601

NDC 972162-1826
NDC 1072162-1826-1
NDC Item72162182601
Packaging100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDAANDA071457
COLORTEXTPINK(pink opaque cap),WHITE(white opaque body)
ColorC48328;C48325 __
DCSACIV
FDA SPL set id774325
Imprint code7;5mg;Novel120
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 72162-1826