Tindamax
Tindamax (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax safely and effectively. See full prescribing information for Tindamax. Tindamax (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004
Approved
Approval ID
a0d01539-8413-4703-94cc-d221918630a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2021
Manufacturers
FDA
Mission Pharmacal Company
DUNS: 008117095
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 Code0178-8500
Application NumberNDA021618
Product Classification
M
Marketing Category
C73594
G
Generic Name
tinidazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2021
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TINIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 033KF7V46H
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
tinidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0178-8250
Application NumberNDA021618
Product Classification
M
Marketing Category
C73594
G
Generic Name
tinidazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2021
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TINIDAZOLEActive
Quantity: 250 mg in 1 1
Code: 033KF7V46H
Classification: ACTIB