DIFLUNISAL
Approved
Approval ID
60e0ecab-9cff-3b1b-e053-2a91aa0af663
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2017
Manufacturers
FDA
H. J. Harkins Company Inc.
DUNS: 147681894
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 Code52959-379
Application NumberANDA073673
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIFLUNISAL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2017
FDA Product Classification
INGREDIENTS (11)
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
DIFLUNISALActive
Quantity: 500 mg in 1 1
Code: 7C546U4DEN
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT