NDC 54348-740

Metronidazole

Metronidazole

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

Product ID54348-740_8f88da1a-09f7-f519-e053-2995a90a0c21
NDC54348-740
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA203458
Labeler NamePharmPak, Inc.
Substance NameMETRONIDAZOLE
Active Ingredient Strength500 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-740-00

1 BOTTLE in 1 BOX (54348-740-00) > 1 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-740-00 [54348074000]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-740-09 [54348074009]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-740-28 [54348074028]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-740-04 [54348074004]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-10

NDC 54348-740-14 [54348074014]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE500 mg/1

Pharmacological Class

  • Nitroimidazole Antimicrobial [EPC]
  • Nitroimidazoles [CS]
  • 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.