NDC 63629-1388

Metronidazole

Metronidazole

Metronidazole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Metronidazole.

Product ID63629-1388_2a60682b-9247-4481-900d-a55c8dd7d1d8
NDC63629-1388
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA203458
Labeler NameBryant Ranch Prepack
Substance NameMETRONIDAZOLE
Active Ingredient Strength250 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-1388-0

7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-0)
Marketing Start Date2022-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-1388-0 [63629138800]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-23
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-4 [63629138804]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-5 [63629138805]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-6 [63629138806]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-2 [63629138802]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-3 [63629138803]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-9 [63629138809]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-23
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-7 [63629138807]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-1 [63629138801]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-1388-8 [63629138808]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA070027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-18
Inactivation Date2020-01-31
Reactivation Date2020-02-25

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE250 mg/1

OpenFDA Data

SPL SET ID:e1e7e127-e99e-80e9-1606-71261658b0c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311681
  • 314106
  • 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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