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NDC properties for NDC 9 0378-1942

NDC item 00378194201

NDC 9	0378-1942
NDC 10	0378-1942-01
NDC Item	00378194201
packaging	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1942-01)
ANDA	ANDA213912
COLORTEXT	GREEN(green opaque),WHITE(white opaque)
Color	C48329;C48325 __
FDA SPL set id	745620
Imprint code	MYLAN;LL;20
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 00378194221

NDC 9	0378-1942
NDC 10	0378-1942-21
NDC Item	00378194221
packaging	21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1942-21)
ANDA	ANDA213912
COLORTEXT	GREEN(green opaque),WHITE(white opaque)
Color	C48329;C48325 __
FDA SPL set id	745620
Imprint code	MYLAN;LL;20
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 00480124521

NDC 9	0480-1245
NDC 10	0480-1245-21
NDC Item	00480124521
packaging	21 CAPSULE in 1 BOTTLE (0480-1245-21)
ANDA	ANDA201452
COLORTEXT	green,blue
Color	C48329;C48333 __
FDA SPL set id	782674
Imprint code	NAT;20mg
Labeler	Teva Pharmaceuticals, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-08
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	18 mm

NDC item 31722026101

NDC 9	31722-261
NDC 10	31722-261-01
NDC Item	31722026101
packaging	100 CAPSULE in 1 BOTTLE (31722-261-01)
ANDA	ANDA212414
COLORTEXT	white,brown
Color	C48325;C48332 __
FDA SPL set id	802288
Imprint code	H;L6
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 31722026121

NDC 9	31722-261
NDC 10	31722-261-21
NDC Item	31722026121
packaging	21 CAPSULE in 1 BOTTLE (31722-261-21)
ANDA	ANDA212414
COLORTEXT	white,brown
Color	C48325;C48332 __
FDA SPL set id	802288
Imprint code	H;L6
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 43598051401

NDC 9	43598-514
NDC 10	43598-514-01
NDC Item	43598051401
packaging	100 CAPSULE in 1 BOTTLE (43598-514-01)
ANDA	ANDA209348
COLORTEXT	YELLOW(yellow opaque colored cap),BLUE(blue opaque colored body)
Color	C48330;C48333 __
FDA SPL set id	727151
Imprint code	RDY;20;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	21 mm

NDC item 43598051421

NDC 9	43598-514
NDC 10	43598-514-21
NDC Item	43598051421
packaging	21 CAPSULE in 1 BOTTLE (43598-514-21)
ANDA	ANDA209348
COLORTEXT	YELLOW(yellow opaque colored cap),BLUE(blue opaque colored body)
Color	C48330;C48333 __
FDA SPL set id	727151
Imprint code	RDY;20;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	21 mm

NDC item 47781048701

NDC 9	47781-487
NDC 10	47781-487-01
NDC Item	47781048701
packaging	100 CAPSULE in 1 BOTTLE (47781-487-01)
ANDA	ANDA210480
COLORTEXT	RED(warm brick red),GRAY(light gray)
Color	C48326;C48324 __
FDA SPL set id	789803
Imprint code	LP;641
Labeler	Alvogen, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 47781048777

NDC 9	47781-487
NDC 10	47781-487-77
NDC Item	47781048777
packaging	21 CAPSULE in 1 BOTTLE (47781-487-77)
ANDA	ANDA210480
COLORTEXT	RED(warm brick red),GRAY(light gray)
Color	C48326;C48324 __
FDA SPL set id	789803
Imprint code	LP;641
Labeler	Alvogen, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-06
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	19 mm

NDC item 59651034601

NDC 9	59651-346
NDC 10	59651-346-01
NDC Item	59651034601
packaging	100 CAPSULE in 1 BOTTLE (59651-346-01)
ANDA	ANDA213885
COLORTEXT	ORANGE(Orange Opaque Cap, Orange Opaque Body)
Color	C48331 __
FDA SPL set id	717399
Imprint code	L;20
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 59651034607

NDC 9	59651-346
NDC 10	59651-346-07
NDC Item	59651034607
packaging	1 BLISTER PACK in 1 CARTON (59651-346-07) / 7 CAPSULE in 1 BLISTER PACK
ANDA	ANDA213885
COLORTEXT	ORANGE(Orange Opaque Cap, Orange Opaque Body)
Color	C48331 __
FDA SPL set id	717399
Imprint code	L;20
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 59651034621

NDC 9	59651-346
NDC 10	59651-346-21
NDC Item	59651034621
packaging	21 CAPSULE in 1 BOTTLE (59651-346-21)
ANDA	ANDA213885
COLORTEXT	ORANGE(Orange Opaque Cap, Orange Opaque Body)
Color	C48331 __
FDA SPL set id	717399
Imprint code	L;20
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 60505453602

NDC 9	60505-4536
NDC 10	60505-4536-2
NDC Item	60505453602
packaging	21 CAPSULE in 1 BOTTLE (60505-4536-2)
ANDA	ANDA211022
COLORTEXT	BLUE(powder blue opaque),BLUE(Blue green opaque)
Color	C48333;C48333 __
FDA SPL set id	794910
Imprint code	APO;L20
Labeler	Apotex Corp.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-09
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	14 mm

NDC item 63304004501

NDC 9	63304-045
NDC 10	63304-045-01
NDC Item	63304004501
packaging	100 CAPSULE in 1 BOTTLE (63304-045-01)
ANDA	ANDA211846
COLORTEXT	white,white
Color	C48325;C48325 __
FDA SPL set id	701728
Imprint code	RL;;82
Labeler	Sun Pharmaceutical Industries, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-12
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 63304004522

NDC 9	63304-045
NDC 10	63304-045-22
NDC Item	63304004522
packaging	21 CAPSULE in 1 BOTTLE (63304-045-22)
ANDA	ANDA211846
COLORTEXT	white,white
Color	C48325;C48325 __
FDA SPL set id	701728
Imprint code	RL;;82
Labeler	Sun Pharmaceutical Industries, Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-12
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	21 mm

NDC item 69097038481

NDC 9	69097-384
NDC 10	69097-384-81
NDC Item	69097038481
packaging	21 CAPSULE in 1 BOTTLE (69097-384-81)
ANDA	ANDA210435
COLORTEXT	BLUE(blue green and pale blue)
Color	C48333 __
FDA SPL set id	698711
Imprint code	cipla20mg;384
Labeler	Cipla USA Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-07
Marketing status	ACTIVE
Score	1
Shape	C48336
Size	22 mm

NDC item 70710103401

NDC 9	70710-1034
NDC 10	70710-1034-1
NDC Item	70710103401
packaging	100 CAPSULE in 1 BOTTLE (70710-1034-1)
ANDA	ANDA210154
COLORTEXT	BLUE(light blue opaque cap turquoise blue opaque body)
Color	C48333 __
FDA SPL set id	770365
Imprint code	1034
Labeler	Zydus Pharmaceuticals USA Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-07
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	19 mm

NDC item 70710103408

NDC 9	70710-1034
NDC 10	70710-1034-8
NDC Item	70710103408
packaging	21 CAPSULE in 1 BOTTLE (70710-1034-8)
ANDA	ANDA210154
COLORTEXT	BLUE(light blue opaque cap turquoise blue opaque body)
Color	C48333 __
FDA SPL set id	770365
Imprint code	1034
Labeler	Zydus Pharmaceuticals USA Inc.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-07
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	19 mm

NDC item 70771168001

NDC 9	70771-1680
NDC 10	70771-1680-1
NDC Item	70771168001
packaging	100 CAPSULE in 1 BOTTLE (70771-1680-1)
ANDA	ANDA210154
COLORTEXT	BLUE(light blue opaque cap turquoise blue opaque body)
Color	C48333 __
FDA SPL set id	800438
Imprint code	1034
Labeler	Zydus Lifesciences Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-07
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	19 mm

NDC item 70771168008

NDC 9	70771-1680
NDC 10	70771-1680-8
NDC Item	70771168008
packaging	21 CAPSULE in 1 BOTTLE (70771-1680-8)
ANDA	ANDA210154
COLORTEXT	BLUE(light blue opaque cap turquoise blue opaque body)
Color	C48333 __
FDA SPL set id	800438
Imprint code	1034
Labeler	Zydus Lifesciences Limited
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2023-03-07
Marketing status	ACTIVE
Score	1
Shapetext	capsule
Shape	C48336
Size	19 mm

NDC item 76282070047

NDC 9	76282-700
NDC 10	76282-700-47
NDC Item	76282070047
packaging	21 CAPSULE in 1 BOTTLE, PLASTIC (76282-700-47)
ANDA	ANDA210435
COLORTEXT	WHITE(Blue green and Pale blue)
Color	C48325 __
FDA SPL set id	792852
Imprint code	Cipla20mg;384
Labeler	EXELAN PHARMACEUTICALS INC.
Label type	HUMAN PRESCRIPTION DRUG
Marketing category	ANDA
Marketing effective time low	2024-06-10
Marketing status	active
Score	1
Shape	C48336
Size	22 mm