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AZATHIOPRINE

Azathioprine Tablets, USP (50 mg, 75 mg and 100 mg) Rx only

Approved
Approval ID

59f3219f-898f-4d05-a430-c2b3f5255af1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2023

Manufacturers
FDA

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

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 Code60219-1076
Application NumberANDA074069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2023
FDA Product Classification

INGREDIENTS (6)

POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
AZATHIOPRINEActive
Quantity: 50 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT

Azathioprine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60219-2036
Application NumberANDA074069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2023
FDA Product Classification

INGREDIENTS (6)

STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
AZATHIOPRINEActive
Quantity: 75 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT

Azathioprine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60219-2037
Application NumberANDA074069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azathioprine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2023
FDA Product Classification

INGREDIENTS (6)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
AZATHIOPRINEActive
Quantity: 100 mg in 1 1
Code: MRK240IY2L
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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AZATHIOPRINE - FDA Drug Approval Details