NDC 53002-1611

Tinidazole

Tinidazole

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

Product ID53002-1611_02bf8a75-9cc8-4eb6-a0e5-ea0a6a27cc39
NDC53002-1611
Product TypeHuman Prescription Drug
Proprietary NameTinidazole
Generic NameTinidazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA203808
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameTINIDAZOLE
Active Ingredient Strength500 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53002-1611-1

10 TABLET in 1 BOTTLE (53002-1611-1)
Marketing Start Date2019-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1611-1 [53002161101]

Tinidazole TABLET
Marketing CategoryANDA
Application NumberANDA203808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TINIDAZOLE500 mg/1

OpenFDA Data

SPL SET ID:ebe89ab6-24c0-4214-853f-67e2e0c7daa9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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

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