Diflunisal
Diflunisal Tablets, USPRx only
Approved
Approval ID
7a78bb38-14d8-4a90-b883-482d4cebf716
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2021
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diflunisal
PRODUCT DETAILS
NDC Product Code0093-9222
Application NumberANDA073673
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 29, 2021
Generic NameDiflunisal
INGREDIENTS (10)
DIFLUNISALActive
Quantity: 500 mg in 1 1
Code: 7C546U4DEN
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT