Tindazole
These highlights do not include all the information needed to use Tinidazole Tablets safely and effectively. See full prescribing information for Tinidazole Tablets. Tinidazole Tablets, for oral use Initial U.S. Approval 2004
Approved
Approval ID
f4235736-3050-1ee0-e053-2a95a90a421c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2023
Manufacturers
FDA
Redpharm Drug, Inc.
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tinidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-1836
Application NumberANDA202489
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tinidazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2023
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TINIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 033KF7V46H
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT