Azathioprine by Cadila Healthcare Limited AZATHIOPRINE tablet

Azathioprine by

Drug Labeling and Warnings

Azathioprine by is a Prescription medication manufactured, distributed, or labeled by Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1140-1 in bottle of 100 tablets

Azathioprine Tablets USP, 75 mg

100 tablets

Rx only

75 mg label

PRINCIPAL DISPLAY PANEL

NDC: 70771-1141-1 in bottle of 100 tablets

Azathioprine Tablets USP, 100 mg

100 tablets

Rx only

100 mg label

PRINCIPAL DISPLAY PANEL

NDC: 70771-1139-1 in bottle of 100 tablets

Azathioprine Tablets USP, 25 mg

100 tablets

Rx only

25 mg label

INGREDIENTS AND APPEARANCE

AZATHIOPRINE 
azathioprine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1139
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)	AZATHIOPRINE	25

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	YELLOW (YELLOW)	Score	2 pieces
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	ZD;11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1139-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2017
2	NDC: 70771-1139-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077621	12/02/2017

AZATHIOPRINE 
azathioprine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1140
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)	AZATHIOPRINE	75

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	YELLOW (YELLOW)	Score	2 pieces
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	ZD;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1140-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2017
2	NDC: 70771-1140-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077621	12/02/2017

AZATHIOPRINE 
azathioprine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1141
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)	AZATHIOPRINE	100

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	YELLOW (YELLOW)	Score	2 pieces
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	ZD;09
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1141-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2017
2	NDC: 70771-1141-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077621	12/02/2017

Labeler - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Cadila Healthcare Limited		918596198	ANALYSIS(70771-1139, 70771-1140, 70771-1141) , MANUFACTURE(70771-1139, 70771-1140, 70771-1141)