Diflunisal
Diflunisal Tablets, USP
Approved
Approval ID
d7a722be-4612-4b2e-827d-56fb5eef0aae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diflunisal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1083
Application NumberANDA203547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diflunisal
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2022
FDA Product Classification
INGREDIENTS (11)
DIFLUNISALActive
Quantity: 500 mg in 1 1
Code: 7C546U4DEN
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT