NDC 0054-0348

Tinidazole

Tinidazole

Tinidazole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Tinidazole.

Product ID0054-0348_2e949dd0-97fa-4216-babe-0686f869208b
NDC0054-0348
Product TypeHuman Prescription Drug
Proprietary NameTinidazole
Generic NameTinidazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA201172
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameTINIDAZOLE
Active Ingredient Strength500 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0348-07

20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
Marketing Start Date2012-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0348-07 [00054034807]

Tinidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201172
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-30

NDC 0054-0348-21 [00054034821]

Tinidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201172
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-30

Drug Details

Active Ingredients

IngredientStrength
TINIDAZOLE500 mg/1

OpenFDA Data

SPL SET ID:4d5ea1c2-6126-432f-be61-44fb24d67b7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477234
  • 199519
    • UPC Code
  • 0300540347161
  • 0300540348076

    • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

    NDC Crossover Matching brand name "Tinidazole" or generic name "Tinidazole"

    NDCBrand NameGeneric Name
    0054-0347TinidazoleTinidazole
    0054-0348TinidazoleTinidazole
    40032-550TinidazoleTinidazole
    40032-551TinidazoleTinidazole
    42799-207TinidazoleTinidazole
    42799-208TinidazoleTinidazole
    43386-550TinidazoleTinidazole
    43386-551TinidazoleTinidazole
    44523-425TinidazoleTinidazole
    44523-450TinidazoleTinidazole
    53002-1611TinidazoleTinidazole
    63629-8386TinidazoleTinidazole
    67296-1729TinidazoleTinidazole
    0178-8250Tindamaxtinidazole
    0178-8500Tindamaxtinidazole
    16571-214TindazoleTinidazole
    16571-215TindazoleTinidazole
    64980-426TindazoleTinidazole
    64980-427TindazoleTinidazole
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