NDC 46708-435

Metronidazole

Metronidazole

Metronidazole is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Metronidazole.

Product ID46708-435_387053e5-7eda-4282-b58a-5789430a2e99
NDC46708-435
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-12-09
Marketing CategoryANDA / ANDA
Application NumberANDA079065
Labeler NameAlembic Pharmaceuticals Limited
Substance NameMETRONIDAZOLE
Active Ingredient Strength375 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46708-435-30

30 CAPSULE in 1 BOTTLE (46708-435-30)
Marketing Start Date2016-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-435-71 [46708043571]

Metronidazole CAPSULE
Marketing CategoryANDA
Application NumberANDA079065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-09

NDC 46708-435-91 [46708043591]

Metronidazole CAPSULE
Marketing CategoryANDA
Application NumberANDA079065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-09

NDC 46708-435-30 [46708043530]

Metronidazole CAPSULE
Marketing CategoryANDA
Application NumberANDA079065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-09

NDC 46708-435-31 [46708043531]

Metronidazole CAPSULE
Marketing CategoryANDA
Application NumberANDA079065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-09

NDC 46708-435-50 [46708043550]

Metronidazole CAPSULE
Marketing CategoryANDA
Application NumberANDA079065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-09

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE375 mg/1

OpenFDA Data

SPL SET ID:387053e5-7eda-4282-b58a-5789430a2e99
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199055
    • UPC Code
  • 0346708435301

    • 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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