AZATHIOPRINE
Azathioprine Tablets, USP Rx only
Approved
Approval ID
f93d9408-7b3f-b423-e053-6294a90a31ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
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 Code42291-063
Application NumberANDA074069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
AZATHIOPRINEActive
Quantity: 100 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB