Tinidazole
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
95ab57b2-5d7e-4986-abcd-65edf1728383
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2022
Manufacturers
FDA
Lupin Pharmaceuticals,Inc.
DUNS: 089153071
Products 2
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 Code43386-551
Application NumberANDA202044
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tinidazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2019
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TINIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 033KF7V46H
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Tinidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43386-550
Application NumberANDA202044
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tinidazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2019
FDA Product Classification
INGREDIENTS (10)
TINIDAZOLEActive
Quantity: 250 mg in 1 1
Code: 033KF7V46H
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT