Azathioprine
Azathioprine Tablets, USP Scored Tablets PRODUCT INFORMATION Rx only
Approved
Approval ID
bc6dc4bd-2121-4613-9d90-4a504010c98a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2022
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
Products 4
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 Code67877-494
Application NumberANDA208687
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
AZATHIOPRINEActive
Quantity: 75 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Azathioprine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-495
Application NumberANDA208687
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
AZATHIOPRINEActive
Quantity: 100 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Azathioprine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-493
Application NumberANDA208687
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
AZATHIOPRINEActive
Quantity: 50 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Azathioprine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-492
Application NumberANDA208687
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
AZATHIOPRINEActive
Quantity: 25 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT