AZATHIOPRINE - azathioprine tablet 
Zydus Lifesciences Limited

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Azathioprine Tablets, USP

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

75 mg label

NDC 70771-1141-1 in bottle of 100 tablets

Azathioprine Tablets USP, 100 mg

100 tablets

Rx only

100 mg label

100 mg label

NDC 70771-1139-1 in bottle of 100 tablets

Azathioprine Tablets USP, 25 mg

100 tablets

Rx only

25 mg label

25 mg label

AZATHIOPRINE 
azathioprine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1139
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZD;11
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1139-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
2NDC:70771-1139-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07762112/02/2017
AZATHIOPRINE 
azathioprine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE75 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code ZD;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1140-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
2NDC:70771-1140-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07762112/02/2017
AZATHIOPRINE 
azathioprine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1141
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE100 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZD;09
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1141-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
2NDC:70771-1141-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07762112/02/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1139, 70771-1140, 70771-1141) , MANUFACTURE(70771-1139, 70771-1140, 70771-1141)

Revised: 8/2022
Document Id: 783f0657-1a40-4342-a9f4-7a0ddf22218d
Set id: 89b272f0-ef5c-49e4-820f-fcd7ea8ef066
Version: 5
Effective Time: 20220805
 
Zydus Lifesciences Limited