metronidazole

Product NDC
72162-2468
11-digit product format
721622468
Labeler code
72162
Product ID
72162-2468_33d9cd48-bb46-bad1-e063-6394a90a230f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070772
Marketing category
ANDA
Marketing start
2025-01-04
Substance
METRONIDAZOLE
Active strength
125 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
140QMO216EMETRONIDAZOLE443-48-1METRONIDAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2468-27216224680256 TABLET in 1 BOTTLE (72162-2468-2) 56 tablet2025-03-27NoNoHistorical
72162-2468-572162246805500 TABLET in 1 BOTTLE (72162-2468-5) 500 tablet2025-04-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metronidazole Tablets, USP Rx onlyBryant Ranch Prepack2025-04-28HUMAN PRESCRIPTION DRUG LABEL101