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NDC properties for NDC 9 0378-3110

NDC item 00378311001

NDC 9	0378-3110
NDC 10	0378-3110-01
NDC Item	00378311001
packaging	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
ANDA	ANDA070920
COLORTEXT	ORANGE(peach opaque),WHITE(ivory opaque)
Color	C48331;C48325 __
DCSA	CIV
FDA SPL set id	411913
Imprint code	MYLAN;3110
Labeler	Mylan Pharmaceuticals Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2010-05-18
Marketing status	COMPLETED
Score	1
Shape	C48336
Size	14 mm

NDC item 00406996001

NDC 9	0406-9960
NDC 10	0406-9960-01
NDC Item	00406996001
packaging	100 CAPSULE in 1 BOTTLE (0406-9960-01)
COLORTEXT	pink,blue
Color	C48328;C48333 __
DCSA	CIV
FDA SPL set id	786605
Imprint code	FOR;SLEEP;M;7;5;mg
Labeler	SpecGx LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	NDA
Marketing effective time low	2010-02-23
Marketing status	ACTIVE
NDA	NDA018163
Score	1
Shape	C48336
Size	16 mm

NDC item 00904643604

NDC 9	0904-6436
NDC 10	0904-6436-04
NDC Item	00904643604
packaging	30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
ANDA	ANDA071457
COLORTEXT	PINK(pink opaque cap),WHITE(white opaque body)
Color	C48328;C48325 __
DCSA	CIV
FDA SPL set id	865031
Imprint code	7;5mg;Novel120
Labeler	Major Pharmaceuticals
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2015-03-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 00904643660

NDC 9	0904-6436
NDC 10	0904-6436-60
NDC Item	00904643660
packaging	100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)
ANDA	ANDA071457
COLORTEXT	PINK(pink opaque cap),WHITE(white opaque body)
Color	C48328;C48325 __
DCSA	CIV
FDA SPL set id	865031
Imprint code	7;5mg;Novel120
Labeler	Major Pharmaceuticals
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2015-03-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 43353015230

NDC 9	43353-152
NDC 10	43353-152-30
NDC Item	43353015230
packaging	30 CAPSULE in 1 BOTTLE (43353-152-30)
ANDA	ANDA071457
COLORTEXT	WHITE(opaque body),PINK(opaque cap)
Color	C48325;C48328 __
DCSA	CIV
FDA SPL set id	274934
Imprint code	7;5;mg;Novel;120
Labeler	Aphena Pharma Solutions - Tennessee, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2015-03-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 43353015253

NDC 9	43353-152
NDC 10	43353-152-53
NDC Item	43353015253
packaging	60 CAPSULE in 1 BOTTLE (43353-152-53)
ANDA	ANDA071457
COLORTEXT	WHITE(opaque body),PINK(opaque cap)
Color	C48325;C48328 __
DCSA	CIV
FDA SPL set id	274934
Imprint code	7;5;mg;Novel;120
Labeler	Aphena Pharma Solutions - Tennessee, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2015-03-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 43353015260

NDC 9	43353-152
NDC 10	43353-152-60
NDC Item	43353015260
packaging	90 CAPSULE in 1 BOTTLE (43353-152-60)
ANDA	ANDA071457
COLORTEXT	WHITE(opaque body),PINK(opaque cap)
Color	C48325;C48328 __
DCSA	CIV
FDA SPL set id	274934
Imprint code	7;5;mg;Novel;120
Labeler	Aphena Pharma Solutions - Tennessee, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2015-03-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 43353071130

NDC 9	43353-711
NDC 10	43353-711-30
NDC Item	43353071130
packaging	30 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-30)
ANDA	ANDA070920
COLORTEXT	ORANGE(peach opaque),WHITE(ivory opaque)
Color	C48331;C48325 __
DCSA	CIV
FDA SPL set id	123301
Imprint code	MYLAN;3110
Labeler	Aphena Pharma Solutions - Tennessee, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-10-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 43353071153

NDC 9	43353-711
NDC 10	43353-711-53
NDC Item	43353071153
packaging	60 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-53)
ANDA	ANDA070920
COLORTEXT	ORANGE(peach opaque),WHITE(ivory opaque)
Color	C48331;C48325 __
DCSA	CIV
FDA SPL set id	123301
Imprint code	MYLAN;3110
Labeler	Aphena Pharma Solutions - Tennessee, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-10-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 43353071160

NDC 9	43353-711
NDC 10	43353-711-60
NDC Item	43353071160
packaging	90 CAPSULE in 1 BOTTLE, PLASTIC (43353-711-60)
ANDA	ANDA070920
COLORTEXT	ORANGE(peach opaque),WHITE(ivory opaque)
Color	C48331;C48325 __
DCSA	CIV
FDA SPL set id	123301
Imprint code	MYLAN;3110
Labeler	Aphena Pharma Solutions - Tennessee, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-10-25
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 43547061110

NDC 9	43547-611
NDC 10	43547-611-10
NDC Item	43547061110
packaging	100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10)
ANDA	ANDA201781
COLORTEXT	BLUE(blue opaque/pink opaque)
Color	C48333 __
DCSA	CIV
FDA SPL set id	812831
Imprint code	7;5mg;S611
Labeler	Solco Healthcare U.S., LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-01-05
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	16 mm

NDC item 46708037930

NDC 9	46708-379
NDC 10	46708-379-30
NDC Item	46708037930
packaging	30 CAPSULE in 1 BOTTLE (46708-379-30)
ANDA	ANDA211542
COLORTEXT	BLUE(opaque blue cap opaque pink body)
Color	C48333 __
DCSA	CIV
FDA SPL set id	690537
Imprint code	A222
Labeler	Alembic Pharmaceuticals Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2018-11-27
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	16 mm

NDC item 46708037931

NDC 9	46708-379
NDC 10	46708-379-31
NDC Item	46708037931
packaging	100 CAPSULE in 1 BOTTLE (46708-379-31)
ANDA	ANDA211542
COLORTEXT	BLUE(opaque blue cap opaque pink body)
Color	C48333 __
DCSA	CIV
FDA SPL set id	690537
Imprint code	A222
Labeler	Alembic Pharmaceuticals Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2018-11-27
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	16 mm

NDC item 53489064801

NDC 9	53489-648
NDC 10	53489-648-01
NDC Item	53489064801
packaging	100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
ANDA	ANDA078581
COLORTEXT	white(opaque),turquoise(opaque)
Color	C48325;C48334 __
DCSA	CIV
FDA SPL set id	399603
Imprint code	Mutual;866
Labeler	Sun Pharmaceutical Industries Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2009-09-09
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 62332037930

NDC 9	62332-379
NDC 10	62332-379-30
NDC Item	62332037930
packaging	30 CAPSULE in 1 BOTTLE (62332-379-30)
ANDA	ANDA211542
COLORTEXT	BLUE(opaque blue cap opaque pink body)
Color	C48333 __
DCSA	CIV
FDA SPL set id	707869
Imprint code	A222
Labeler	Alembic Pharmaceuticals Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2018-11-27
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	16 mm

NDC item 62332037931

NDC 9	62332-379
NDC 10	62332-379-31
NDC Item	62332037931
packaging	100 CAPSULE in 1 BOTTLE (62332-379-31)
ANDA	ANDA211542
COLORTEXT	BLUE(opaque blue cap opaque pink body)
Color	C48333 __
DCSA	CIV
FDA SPL set id	707869
Imprint code	A222
Labeler	Alembic Pharmaceuticals Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2018-11-27
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	16 mm

NDC item 63187071815

NDC 9	63187-718
NDC 10	63187-718-15
NDC Item	63187071815
packaging	15 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-15)
ANDA	ANDA078581
COLORTEXT	WHITE(opaque),TURQUOISE(opaque)
Color	C48325;C48334 __
DCSA	CIV
FDA SPL set id	425784
Imprint code	Mutual;866
Labeler	Proficient Rx LP
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2009-09-09
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 63187071820

NDC 9	63187-718
NDC 10	63187-718-20
NDC Item	63187071820
packaging	20 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-20)
ANDA	ANDA078581
COLORTEXT	WHITE(opaque),TURQUOISE(opaque)
Color	C48325;C48334 __
DCSA	CIV
FDA SPL set id	425784
Imprint code	Mutual;866
Labeler	Proficient Rx LP
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2009-09-09
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 63187071830

NDC 9	63187-718
NDC 10	63187-718-30
NDC Item	63187071830
packaging	30 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-30)
ANDA	ANDA078581
COLORTEXT	WHITE(opaque),TURQUOISE(opaque)
Color	C48325;C48334 __
DCSA	CIV
FDA SPL set id	425784
Imprint code	Mutual;866
Labeler	Proficient Rx LP
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2009-09-09
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 63187071860

NDC 9	63187-718
NDC 10	63187-718-60
NDC Item	63187071860
packaging	60 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-60)
ANDA	ANDA078581
COLORTEXT	WHITE(opaque),TURQUOISE(opaque)
Color	C48325;C48334 __
DCSA	CIV
FDA SPL set id	425784
Imprint code	Mutual;866
Labeler	Proficient Rx LP
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2009-09-09
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 63187071890

NDC 9	63187-718
NDC 10	63187-718-90
NDC Item	63187071890
packaging	90 CAPSULE in 1 BOTTLE, PLASTIC (63187-718-90)
ANDA	ANDA078581
COLORTEXT	WHITE(opaque),TURQUOISE(opaque)
Color	C48325;C48334 __
DCSA	CIV
FDA SPL set id	425784
Imprint code	Mutual;866
Labeler	Proficient Rx LP
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2009-09-09
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 63629860101

NDC 9	63629-8601
NDC 10	63629-8601-1
NDC Item	63629860101
packaging	100 CAPSULE in 1 BOTTLE (63629-8601-1)
ANDA	ANDA071457
COLORTEXT	PINK(pink opaque cap),WHITE(white opaque body)
Color	C48328;C48325 __
DCSA	CIV
FDA SPL set id	801649
Imprint code	7;5mg;Novel120
Labeler	Bryant Ranch Prepack
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-06-28
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 63739000333

NDC 9	63739-003
NDC 10	63739-003-33
NDC Item	63739000333
packaging	3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK
ANDA	ANDA071457
COLORTEXT	white(white opaque body),pink(pink opaque cap)
Color	C48325;C48328 __
DCSA	CIV
FDA SPL set id	853339
Imprint code	7;5mg;Novel120
Labeler	McKesson Corporation dba SKY Packaging
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time high	2025-10-31
Marketing effective time low	2012-06-28
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 65162058303

NDC 9	65162-583
NDC 10	65162-583-03
NDC Item	65162058303
packaging	30 CAPSULE in 1 BOTTLE (65162-583-03)
ANDA	ANDA203482
COLORTEXT	white(OPAQUE BODY),blue(OPAQUE CAP)
Color	C48325;C48333 __
DCSA	CIV
FDA SPL set id	824881
Imprint code	AMNEAL;583
Labeler	Amneal Pharmaceuticals LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2016-05-23
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 65162058310

NDC 9	65162-583
NDC 10	65162-583-10
NDC Item	65162058310
packaging	100 CAPSULE in 1 BOTTLE (65162-583-10)
ANDA	ANDA203482
COLORTEXT	white(OPAQUE BODY),blue(OPAQUE CAP)
Color	C48325;C48333 __
DCSA	CIV
FDA SPL set id	824881
Imprint code	AMNEAL;583
Labeler	Amneal Pharmaceuticals LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2016-05-23
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 65162058311

NDC 9	65162-583
NDC 10	65162-583-11
NDC Item	65162058311
packaging	1000 CAPSULE in 1 BOTTLE (65162-583-11)
ANDA	ANDA203482
COLORTEXT	white(OPAQUE BODY),blue(OPAQUE CAP)
Color	C48325;C48333 __
DCSA	CIV
FDA SPL set id	824881
Imprint code	AMNEAL;583
Labeler	Amneal Pharmaceuticals LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2016-05-23
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 65162058350

NDC 9	65162-583
NDC 10	65162-583-50
NDC Item	65162058350
packaging	500 CAPSULE in 1 BOTTLE (65162-583-50)
ANDA	ANDA203482
COLORTEXT	white(OPAQUE BODY),blue(OPAQUE CAP)
Color	C48325;C48333 __
DCSA	CIV
FDA SPL set id	824881
Imprint code	AMNEAL;583
Labeler	Amneal Pharmaceuticals LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2016-05-23
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 67877014801

NDC 9	67877-148
NDC 10	67877-148-01
NDC Item	67877014801
packaging	100 CAPSULE in 1 BOTTLE (67877-148-01)
ANDA	ANDA071457
COLORTEXT	PINK(pink opaque cap),WHITE(white opaque body)
Color	C48328;C48325 __
DCSA	CIV
FDA SPL set id	757749
Imprint code	7;5mg;Novel120
Labeler	Ascend Laboratories, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-06-28
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 67877014805

NDC 9	67877-148
NDC 10	67877-148-05
NDC Item	67877014805
packaging	500 CAPSULE in 1 BOTTLE (67877-148-05)
ANDA	ANDA071457
COLORTEXT	PINK(pink opaque cap),WHITE(white opaque body)
Color	C48328;C48325 __
DCSA	CIV
FDA SPL set id	757749
Imprint code	7;5mg;Novel120
Labeler	Ascend Laboratories, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-06-28
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 67877014830

NDC 9	67877-148
NDC 10	67877-148-30
NDC Item	67877014830
packaging	30 CAPSULE in 1 BOTTLE (67877-148-30)
ANDA	ANDA071457
COLORTEXT	PINK(pink opaque cap),WHITE(white opaque body)
Color	C48328;C48325 __
DCSA	CIV
FDA SPL set id	757749
Imprint code	7;5mg;Novel120
Labeler	Ascend Laboratories, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-06-28
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 68084054911

NDC 9	68084-549
NDC 10	68084-549-11
NDC Item	68084054911
packaging	1 in 1 BLISTER PACK
COLORTEXT	pink,blue
Color	C48328;C48333 __
DCSA	CIV
FDA SPL set id	767934
Imprint code	FOR;SLEEP;M;7;5;mg
Labeler	American Health Packaging
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	NDA
Marketing effective time low	2012-08-01
Marketing status	ACTIVE
NDA	NDA018163
Score	1
Shape	C48336
Size	16 mm

NDC item 68084054921

NDC 9	68084-549
NDC 10	68084-549-21
NDC Item	68084054921
packaging	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11)
COLORTEXT	pink,blue
Color	C48328;C48333 __
DCSA	CIV
FDA SPL set id	767934
Imprint code	FOR;SLEEP;M;7;5;mg
Labeler	American Health Packaging
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	NDA
Marketing effective time low	2012-08-01
Marketing status	ACTIVE
NDA	NDA018163
Score	1
Shape	C48336
Size	16 mm

NDC item 71610000430

NDC 9	71610-004
NDC 10	71610-004-30
NDC Item	71610000430
packaging	30 CAPSULE in 1 BOTTLE (71610-004-30)
COLORTEXT	PINK,BLUE
Color	C48328;C48333 __
DCSA	CIV
FDA SPL set id	382465
Imprint code	FOR;SLEEP;M;7;5;mg
Labeler	Aphena Pharma Solutions - Tennessee, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	NDA
Marketing effective time low	2010-02-23
Marketing status	ACTIVE
NDA	NDA018163
Score	1
Shape	C48336
Size	16 mm

NDC item 71610000453

NDC 9	71610-004
NDC 10	71610-004-53
NDC Item	71610000453
packaging	60 CAPSULE in 1 BOTTLE (71610-004-53)
COLORTEXT	PINK,BLUE
Color	C48328;C48333 __
DCSA	CIV
FDA SPL set id	382465
Imprint code	FOR;SLEEP;M;7;5;mg
Labeler	Aphena Pharma Solutions - Tennessee, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	NDA
Marketing effective time low	2010-02-23
Marketing status	ACTIVE
NDA	NDA018163
Score	1
Shape	C48336
Size	16 mm

NDC item 71610000460

NDC 9	71610-004
NDC 10	71610-004-60
NDC Item	71610000460
packaging	90 CAPSULE in 1 BOTTLE (71610-004-60)
COLORTEXT	PINK,BLUE
Color	C48328;C48333 __
DCSA	CIV
FDA SPL set id	382465
Imprint code	FOR;SLEEP;M;7;5;mg
Labeler	Aphena Pharma Solutions - Tennessee, LLC
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	NDA
Marketing effective time low	2010-02-23
Marketing status	ACTIVE
NDA	NDA018163
Score	1
Shape	C48336
Size	16 mm

NDC item 72162182601

NDC 9	72162-1826
NDC 10	72162-1826-1
NDC Item	72162182601
packaging	100 CAPSULE in 1 BOTTLE (72162-1826-1)
ANDA	ANDA071457
COLORTEXT	PINK(pink opaque cap),WHITE(white opaque body)
Color	C48328;C48325 __
DCSA	CIV
FDA SPL set id	774325
Imprint code	7;5mg;Novel120
Labeler	Bryant Ranch Prepack
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2012-06-28
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm