AZATHIOPRINE
AZATHIOPRINE Tablets USP, 50 mg
Approved
Approval ID
2f994aed-f8e7-4967-a167-b22b783b4192
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 5, 2018
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-124
Application NumberANDA074069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 5, 2018
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
AZATHIOPRINEActive
Quantity: 50 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT