NDC 40032-551

Tinidazole

Tinidazole

Tinidazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novel Laboratories, Inc.. The primary component is Tinidazole.

Product ID40032-551_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae
NDC40032-551
Product TypeHuman Prescription Drug
Proprietary NameTinidazole
Generic NameTinidazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA202044
Labeler NameNovel Laboratories, Inc.
Substance NameTINIDAZOLE
Active Ingredient Strength500 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 40032-551-20

20 TABLET in 1 BOTTLE (40032-551-20)
Marketing Start Date2012-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 40032-551-60 [40032055160]

Tinidazole TABLET
Marketing CategoryANDA
Application NumberANDA202044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Inactivation Date2020-01-31

NDC 40032-551-20 [40032055120]

Tinidazole TABLET
Marketing CategoryANDA
Application NumberANDA202044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TINIDAZOLE500 mg/1

OpenFDA Data

SPL SET ID:4e03b4ac-c88a-4044-9d58-0cfcda3db53c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477234
  • 199519
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.