Azathioprine
Azathioprine Tablets, USP
Approved
Approval ID
1cd03d78-d567-4449-be98-0e8652ceff6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azathioprine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-118
Application NumberANDA077621
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (6)
AZATHIOPRINEActive
Quantity: 25 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Azathioprine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-120
Application NumberANDA077621
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
AZATHIOPRINEActive
Quantity: 100 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Azathioprine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-119
Application NumberANDA077621
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AZATHIOPRINEActive
Quantity: 75 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT