NDC 63187-035

Metronidazole

Metronidazole

Metronidazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Metronidazole.

Product ID63187-035_62667034-bf5e-4582-a510-b46b4b3725d0
NDC63187-035
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1990-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA070033
Labeler NameProficient Rx LP
Substance NameMETRONIDAZOLE
Active Ingredient Strength500 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63187-035-04

4 TABLET in 1 BOTTLE (63187-035-04)
Marketing Start Date2021-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-035-14 [63187003514]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070033
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 63187-035-21 [63187003521]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070033
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 63187-035-30 [63187003530]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070033
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE500 mg/1

OpenFDA Data

SPL SET ID:e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311681

    • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

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

    NDCBrand NameGeneric Name
    0115-1474MetronidazoleMetronidazole
    0143-9772MetronidazoleMetronidazole
    0168-0275MetronidazoleMetronidazole
    0168-0323MetronidazoleMetronidazole
    0168-0383MetronidazoleMetronidazole
    0179-1482MetronidazoleMetronidazole
    0264-5535METRONIDAZOLEMETRONIDAZOLE
    0338-1055MetronidazoleMetronidazole
    68001-364MetronidazoleMetronidazole
    68001-229MetronidazoleMetronidazole
    68001-365MetronidazoleMetronidazole
    68001-263MetronidazoleMetronidazole
    68071-1753MetronidazoleMetronidazole
    68071-2196MetronidazoleMetronidazole
    68071-1939MetronidazoleMetronidazole
    68071-1876MetronidazoleMetronidazole
    0409-7811MetronidazoleMetronidazole
    68071-3039MetronidazoleMetronidazole
    68084-966MetronidazoleMetronidazole
    0440-1795MetronidazoleMetronidazole
    68084-216MetronidazoleMetronidazole
    0440-1796MetronidazoleMetronidazole
    68151-2007MetronidazoleMetronidazole
    68382-850metronidazolemetronidazole
    68382-851metronidazolemetronidazole
    68682-455MetronidazoleMetronidazole
    68788-6843MetronidazoleMetronidazole
    68788-6930MetronidazoleMetronidazole
    68788-9082MetronidazoleMetronidazole
    68788-6960MetronidazoleMetronidazole
    68788-9505MetronidazoleMetronidazole
    68788-9372MetronidazoleMetronidazole
    68788-9397MetronidazoleMetronidazole
    68788-8930MetronidazoleMetronidazole
    68788-9083MetronidazoleMetronidazole
    68788-7381MetronidazoleMetronidazole
    69007-836METRONIDAZOLEMETRONIDAZOLE
    69043-004MetronidazoleMetronidazole
    69043-005MetronidazoleMetronidazole
    69292-206metronidazolemetronidazole
    70518-0090MetronidazoleMetronidazole
    70518-0058MetronidazoleMetronidazole
    70518-0013MetronidazoleMetronidazole
    70518-0324MetronidazoleMetronidazole
    70518-0088MetronidazoleMetronidazole
    70518-0539MetronidazoleMetronidazole
    0591-2521MetronidazoleMetronidazole
    70518-0797MetronidazoleMetronidazole
    70518-1536MetronidazoleMetronidazole
    0591-5215MetronidazoleMetronidazole
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