Tinidazole
Tinidazole 500mg
Approved
Approval ID
9719883b-496d-42bb-e053-2995a90a1ab1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2021
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 Code67296-1729
Application NumberANDA201172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tinidazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (11)
TINIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 033KF7V46H
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT