RxSearch

NDC properties for "temazepam 22.5 MG Oral Capsule" (RxCUI 485489)

About this data

The tables show NDC propoerties for temazepam 22.5 MG Oral Capsule with the RxCUI 485489

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 22.5 MG Oral Capsule (RxCUI 485489)

ANDAANDA071457
ANDAANDA201781
ANDAANDA203482
ANDAANDA211542
MMSL_CODEBD13300
MMSL_CODECD13300
NDANDA018163
RxCUI485489
SNOMEDCT430273009
SPL_SET_ID1e37d59b-b8be-46ef-8706-fffd563a8c15
SPL_SET_ID3ce42f0e-821e-4c9a-8f6b-60621628fd4b
SPL_SET_ID74a3db09-94d0-45e1-8c68-da7ca49d3d59
SPL_SET_ID7e9c51d4-032b-48ab-9c19-6050d1e86512
SPL_SET_ID85327378-86a3-4448-9185-e20bb20ebf45
SPL_SET_ID8f54731f-c5b7-492c-acb0-444c5fbb7029
SPL_SET_ID93b1be7f-ec41-46bb-a258-56cb459e2c92
SPL_SET_IDbcfd6a3d-66eb-4844-bede-6ec671985b2c
SPL_SET_IDbe68c6e0-17ad-40fe-9bc1-58abe24b53f6
SPL_SET_IDc9bc61b4-a579-4003-98da-b6f6e381c150
SPL_SET_IDdadc2f66-7fa5-4be4-a9d0-d96e5836f550
SPL_SET_IDdb839409-8e95-41d3-804e-dcd5d11f4934
SPL_SET_IDdbea1ee6-cdaa-4b1a-8dd5-4bff31b2a1ef
SPL_SET_IDf1ff672d-0b95-4e1b-9104-a545e02f4ee7
VUID4025744
Prescribable Synonymtemazepam 22.5 MG Oral Capsule
RXNAV_STRtemazepam 22.5 MG Oral Capsule
RxNorm Nametemazepam 22.5 MG Oral Capsule
Related queriesInteractions (for RxCUI 485489)



NDC Properties

NDC Item 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0378-3120

NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 0406-9959

NDC Item 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 35356-821

NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 43547-613

NDC Item 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 46708-381

NDC Item 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 50436-4630

NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-650

NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 60760-959

NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 62332-381

NDC Item 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 63629-8604

NDC Item 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71335-2043

NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 72162-1827

NDC Item 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0378-3120

NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 0406-9959

NDC Item 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 35356-821

NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 43547-613

NDC Item 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 46708-381

NDC Item 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 50436-4630

NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-650

NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 60760-959

NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 62332-381

NDC Item 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 63629-8604

NDC Item 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 72162-1827

NDC Item 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 63629-8604

NDC Item 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71335-2043

NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 72162-1827

NDC Item 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0378-3120

NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 0406-9959

NDC Item 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 35356-821

NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 43547-613

NDC Item 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 46708-381

NDC Item 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 50436-4630

NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 53489-650

NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 60760-959

NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 62332-381

NDC Item 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 63629-8604

NDC Item 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71335-2043

NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 72162-1827

NDC Item 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 0378-3120

NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 72162-1827

NDC Item 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
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NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 00378312093

NDC 90378-3120
NDC 100378-3120-93
NDC Item00378312093
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)
ANDAANDA070920
COLORTEXTYELLOW(yellow opaque),ORANGE(peach opaque)
ColorC48330;C48331 __
DCSACIV
FDA SPL set id411913
Imprint codeMYLAN;3120
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2019-10-31
Marketing effective time low2009-06-15
Marketing statusCOMPLETED
Score1
ShapeC48336
Size16 mm
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NDC Item 00406995903

NDC 90406-9959
NDC 100406-9959-03
NDC Item00406995903
Packaging30 CAPSULE in 1 BOTTLE (0406-9959-03)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id786605
Imprint codeFOR;SLEEP;M;22;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 35356082130

NDC 935356-821
NDC 1035356-821-30
NDC Item35356082130
Packaging30 CAPSULE in 1 BOTTLE (35356-821-30)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763028
Imprint code22;5mg;Novel122
LabelerLake Erie Medical DBA: Quality Care Products LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusCOMPLETED
Score1
ShapeC48336
Size19 mm
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NDC Item 43547061303

NDC 943547-613
NDC 1043547-613-03
NDC Item43547061303
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)
ANDAANDA201781
COLORTEXTBLUE(Opaque Blue)
ColorC48333 __
DCSACIV
FDA SPL set id812831
Imprint code22;5mg;S613
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 46708038130

NDC 946708-381
NDC 1046708-381-30
NDC Item46708038130
Packaging30 CAPSULE in 1 BOTTLE (46708-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id690537
Imprint codeA224
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 50436463001

NDC 950436-4630
NDC 1050436-4630-1
NDC Item50436463001
Packaging30 CAPSULE in 1 BOTTLE (50436-4630-1)
ANDAANDA071457
COLORTEXTblue(light blue opaque cap),white(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id260509
Imprint code22;5mg;Novel122
LabelerUnit Dose Services
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-06-28
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 53489065007

NDC 953489-650
NDC 1053489-650-07
NDC Item53489065007
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07)
ANDAANDA071175
COLORTEXTwhite(opaque),green(light green opaque)
ColorC48325;C48329 __
DCSACIV
FDA SPL set id399603
Imprint codeMutual;868
LabelerSun Pharmaceutical Industries Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-10-26
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60760095930

NDC 960760-959
NDC 1060760-959-30
NDC Item60760095930
Packaging30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30)
COLORTEXTblue
ColorC48333 __
DCSACIV
FDA SPL set id428380
Imprint codeFOR;SLEEP;M;22;5;mg
LabelerSt. Mary's Medical Park Pharmacy
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA
Marketing effective time low2019-10-24
Marketing statusCOMPLETED
NDANDA018163
Score1
ShapeC48336
Size16 mm
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NDC Item 62332038130

NDC 962332-381
NDC 1062332-381-30
NDC Item62332038130
Packaging30 CAPSULE in 1 BOTTLE (62332-381-30)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id707869
Imprint codeA224
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 63629860401

NDC 963629-8604
NDC 1063629-8604-1
NDC Item63629860401
Packaging30 CAPSULE in 1 BOTTLE (63629-8604-1)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id763276
Imprint code22;5mg;Novel122
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 65162058403

NDC 965162-584
NDC 1065162-584-03
NDC Item65162058403
Packaging30 CAPSULE in 1 BOTTLE (65162-584-03)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058410

NDC 965162-584
NDC 1065162-584-10
NDC Item65162058410
Packaging100 CAPSULE in 1 BOTTLE (65162-584-10)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058411

NDC 965162-584
NDC 1065162-584-11
NDC Item65162058411
Packaging1000 CAPSULE in 1 BOTTLE (65162-584-11)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162058450

NDC 965162-584
NDC 1065162-584-50
NDC Item65162058450
Packaging500 CAPSULE in 1 BOTTLE (65162-584-50)
ANDAANDA203482
COLORTEXTwhite(OPAQUE BODY),pink(DARK PINK OPAQUE)
ColorC48325;C48328 __
DCSACIV
FDA SPL set id824881
Imprint codeAMNEAL;584
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 65162-584

NDC Item 67877014901

NDC 967877-149
NDC 1067877-149-01
NDC Item67877014901
Packaging100 CAPSULE in 1 BOTTLE (67877-149-01)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014905

NDC 967877-149
NDC 1067877-149-05
NDC Item67877014905
Packaging500 CAPSULE in 1 BOTTLE (67877-149-05)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 67877014930

NDC 967877-149
NDC 1067877-149-30
NDC Item67877014930
Packaging30 CAPSULE in 1 BOTTLE (67877-149-30)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id757749
Imprint code22;5mg;Novel122
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 67877-149

NDC Item 71335204301

NDC 971335-2043
NDC 1071335-2043-1
NDC Item71335204301
Packaging30 CAPSULE in 1 BOTTLE (71335-2043-1)
ANDAANDA211542
COLORTEXTBLUE(opaque blue cap opaque blue body)
ColorC48333 __
DCSACIV
FDA SPL set id748413
Imprint codeA224
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-11-27
Marketing statusACTIVE
Score1
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 71335-2043

NDC Item 72162182703

NDC 972162-1827
NDC 1072162-1827-3
NDC Item72162182703
Packaging30 CAPSULE in 1 BOTTLE (72162-1827-3)
ANDAANDA071457
COLORTEXTBLUE(blue opaque cap),WHITE(white opaque body)
ColorC48333;C48325 __
DCSACIV
FDA SPL set id774627
Imprint code22;5mg;Novel122
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 72162-1827