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NDC properties for NDC 9 0378-1937

NDC item 00378193701

NDC 9	0378-1937
NDC 10	0378-1937-01
NDC Item	00378193701
packaging	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1937-01)
ANDA	ANDA213912
COLORTEXT	GREEN(green opaque),GRAY(light gray opaque)
Color	C48329;C48324 __
FDA SPL set id	745620
Imprint code	MYLAN;LL;10
Labeler	Mylan Pharmaceuticals Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	22 mm

NDC item 00378193728

NDC 9	0378-1937
NDC 10	0378-1937-28
NDC Item	00378193728
packaging	28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1937-28)
ANDA	ANDA213912
COLORTEXT	GREEN(green opaque),GRAY(light gray opaque)
Color	C48329;C48324 __
FDA SPL set id	745620
Imprint code	MYLAN;LL;10
Labeler	Mylan Pharmaceuticals Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	22 mm

NDC item 00480124328

NDC 9	0480-1243
NDC 10	0480-1243-28
NDC Item	00480124328
packaging	28 CAPSULE in 1 BOTTLE (0480-1243-28)
ANDA	ANDA201452
COLORTEXT	white
Color	C48325 __
FDA SPL set id	644159
Imprint code	NAT;10mg
Labeler	Teva Pharmaceuticals, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-03-03
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 31722025901

NDC 9	31722-259
NDC 10	31722-259-01
NDC Item	31722025901
packaging	100 CAPSULE in 1 BOTTLE (31722-259-01)
ANDA	ANDA212414
COLORTEXT	orange,white
Color	C48331;C48325 __
FDA SPL set id	802288
Imprint code	H;L4
Labeler	Camber Pharmaceuticals, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-05-11
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	22 mm

NDC item 31722025928

NDC 9	31722-259
NDC 10	31722-259-28
NDC Item	31722025928
packaging	28 CAPSULE in 1 BOTTLE (31722-259-28)
ANDA	ANDA212414
COLORTEXT	orange,white
Color	C48331;C48325 __
FDA SPL set id	802288
Imprint code	H;L4
Labeler	Camber Pharmaceuticals, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-05-11
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	22 mm

NDC item 43598051201

NDC 9	43598-512
NDC 10	43598-512-01
NDC Item	43598051201
packaging	100 CAPSULE in 1 BOTTLE (43598-512-01)
ANDA	ANDA209348
COLORTEXT	YELLOW(yellow opaque colored cap and body)
Color	C48330 __
FDA SPL set id	727151
Imprint code	RDY;10;mg
Labeler	Dr. Reddy's Laboratories Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-07
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 43598051263

NDC 9	43598-512
NDC 10	43598-512-63
NDC Item	43598051263
packaging	28 CAPSULE in 1 BOTTLE (43598-512-63)
ANDA	ANDA209348
COLORTEXT	YELLOW(yellow opaque colored cap and body)
Color	C48330 __
FDA SPL set id	727151
Imprint code	RDY;10;mg
Labeler	Dr. Reddy's Laboratories Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-07
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 47781048501

NDC 9	47781-485
NDC 10	47781-485-01
NDC Item	47781048501
packaging	100 CAPSULE in 1 BOTTLE (47781-485-01)
ANDA	ANDA210480
COLORTEXT	YELLOW(GOLD),GRAY
Color	C48330;C48324 __
FDA SPL set id	789803
Imprint code	LP;639
Labeler	Alvogen, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-03
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	22 mm

NDC item 47781048528

NDC 9	47781-485
NDC 10	47781-485-28
NDC Item	47781048528
packaging	28 CAPSULE in 1 BOTTLE (47781-485-28)
ANDA	ANDA210480
COLORTEXT	YELLOW(GOLD),GRAY
Color	C48330;C48324 __
FDA SPL set id	789803
Imprint code	LP;639
Labeler	Alvogen, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-03
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	22 mm

NDC item 59651034401

NDC 9	59651-344
NDC 10	59651-344-01
NDC Item	59651034401
packaging	100 CAPSULE in 1 BOTTLE (59651-344-01)
ANDA	ANDA213885
COLORTEXT	GREEN(Olive Green Opaque Cap),ORANGE(Orange Opaque Body)
Color	C48329;C48331 __
FDA SPL set id	717399
Imprint code	L;10
Labeler	Aurobindo Pharma Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 59651034407

NDC 9	59651-344
NDC 10	59651-344-07
NDC Item	59651034407
packaging	1 BLISTER PACK in 1 CARTON (59651-344-07) / 7 CAPSULE in 1 BLISTER PACK
ANDA	ANDA213885
COLORTEXT	GREEN(Olive Green Opaque Cap),ORANGE(Orange Opaque Body)
Color	C48329;C48331 __
FDA SPL set id	717399
Imprint code	L;10
Labeler	Aurobindo Pharma Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 59651034428

NDC 9	59651-344
NDC 10	59651-344-28
NDC Item	59651034428
packaging	28 CAPSULE in 1 BOTTLE (59651-344-28)
ANDA	ANDA213885
COLORTEXT	GREEN(Olive Green Opaque Cap),ORANGE(Orange Opaque Body)
Color	C48329;C48331 __
FDA SPL set id	717399
Imprint code	L;10
Labeler	Aurobindo Pharma Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 60505453401

NDC 9	60505-4534
NDC 10	60505-4534-1
NDC Item	60505453401
packaging	100 CAPSULE in 1 BOTTLE (60505-4534-1)
ANDA	ANDA211022
COLORTEXT	BLUE(Blue green opaque),WHITE(Ivory opaque)
Color	C48333;C48325 __
FDA SPL set id	794910
Imprint code	APO;L10
Labeler	Apotex Corp.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 60505453402

NDC 9	60505-4534
NDC 10	60505-4534-2
NDC Item	60505453402
packaging	28 CAPSULE in 1 BOTTLE (60505-4534-2)
ANDA	ANDA211022
COLORTEXT	BLUE(Blue green opaque),WHITE(Ivory opaque)
Color	C48333;C48325 __
FDA SPL set id	794910
Imprint code	APO;L10
Labeler	Apotex Corp.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 63304004301

NDC 9	63304-043
NDC 10	63304-043-01
NDC Item	63304004301
packaging	100 CAPSULE in 1 BOTTLE (63304-043-01)
ANDA	ANDA211846
COLORTEXT	white,white
Color	C48325;C48325 __
FDA SPL set id	701728
Imprint code	RL;;80
Labeler	Sun Pharmaceutical Industries, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-04
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 63304004327

NDC 9	63304-043
NDC 10	63304-043-27
NDC Item	63304004327
packaging	28 CAPSULE in 1 BOTTLE (63304-043-27)
ANDA	ANDA211846
COLORTEXT	white,white
Color	C48325;C48325 __
FDA SPL set id	701728
Imprint code	RL;;80
Labeler	Sun Pharmaceutical Industries, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-04
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 69097038273

NDC 9	69097-382
NDC 10	69097-382-73
NDC Item	69097038273
packaging	28 CAPSULE in 1 BOTTLE, PLASTIC (69097-382-73)
ANDA	ANDA210435
COLORTEXT	GREEN(Blue green and Pale yellow)
Color	C48329 __
FDA SPL set id	698711
Imprint code	Cipla10mg;382
Labeler	Cipla USA Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 70710103201

NDC 9	70710-1032
NDC 10	70710-1032-1
NDC Item	70710103201
packaging	100 CAPSULE in 1 BOTTLE (70710-1032-1)
ANDA	ANDA210154
COLORTEXT	WHITE(white opaque cap),BLUE(Turquoise blue opaque body)
Color	C48325;C48333 __
FDA SPL set id	770365
Imprint code	1032
Labeler	Zydus Pharmaceuticals USA Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-12
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	16 mm

NDC item 70710103207

NDC 9	70710-1032
NDC 10	70710-1032-7
NDC Item	70710103207
packaging	28 CAPSULE in 1 BOTTLE (70710-1032-7)
ANDA	ANDA210154
COLORTEXT	WHITE(white opaque cap),BLUE(Turquoise blue opaque body)
Color	C48325;C48333 __
FDA SPL set id	770365
Imprint code	1032
Labeler	Zydus Pharmaceuticals USA Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-12
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	16 mm

NDC item 70771167801

NDC 9	70771-1678
NDC 10	70771-1678-1
NDC Item	70771167801
packaging	100 CAPSULE in 1 BOTTLE (70771-1678-1)
ANDA	ANDA210154
COLORTEXT	WHITE(White opaque cap),BLUE(Turquoise blue opaque body)
Color	C48325;C48333 __
FDA SPL set id	800438
Imprint code	1032
Labeler	Zydus Lifesciences Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-12
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	16 mm

NDC item 70771167807

NDC 9	70771-1678
NDC 10	70771-1678-7
NDC Item	70771167807
packaging	28 CAPSULE in 1 BOTTLE (70771-1678-7)
ANDA	ANDA210154
COLORTEXT	WHITE(White opaque cap),BLUE(Turquoise blue opaque body)
Color	C48325;C48333 __
FDA SPL set id	800438
Imprint code	1032
Labeler	Zydus Lifesciences Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-12
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	16 mm

NDC item 76282069848

NDC 9	76282-698
NDC 10	76282-698-48
NDC Item	76282069848
packaging	28 CAPSULE in 1 BOTTLE, PLASTIC (76282-698-48)
ANDA	ANDA210435
COLORTEXT	GREEN(Blue green and Pale yellow)
Color	C48329 __
FDA SPL set id	792852
Imprint code	Cipla10mg;382
Labeler	EXELAN PHARMACEUTICALS INC.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2022-09-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm