Azasan
Azathioprine Tablets, 75mg and 100mg
Approved
Approval ID
9050af7a-19c6-4670-937a-9445605de995
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Salix Pharmaceuticals
DUNS: 793108036
Products 2
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 Code65649-231
Application NumberANDA075252
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (6)
AZATHIOPRINEActive
Quantity: 75 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Azathioprine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65649-241
Application NumberANDA075252
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (6)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AZATHIOPRINEActive
Quantity: 100 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT