NDC 43386-550

Tinidazole

Tinidazole

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

Product ID43386-550_779bb927-73bc-4e80-b1fd-66bd150615d2
NDC43386-550
Product TypeHuman Prescription Drug
Proprietary NameTinidazole
Generic NameTinidazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA202044
Labeler NameLupin Pharmaceuticals,Inc.
Substance NameTINIDAZOLE
Active Ingredient Strength250 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43386-550-04

40 TABLET in 1 BOTTLE (43386-550-04)
Marketing Start Date2012-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43386-550-04 [43386055004]

Tinidazole TABLET
Marketing CategoryANDA
Application NumberANDA202044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-30

NDC 43386-550-40 [43386055040]

Tinidazole TABLET
Marketing CategoryANDA
Application NumberANDA202044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Marketing End Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
TINIDAZOLE250 mg/1

OpenFDA Data

SPL SET ID:95ab57b2-5d7e-4986-abcd-65edf1728383
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477234
  • 199519
  • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

    Medicade Reported Pricing

    43386055004 TINIDAZOLE 250 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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