Metronidazole

Product NDC
68071-2280
11-digit product format
680712280
Labeler code
68071
Product ID
68071-2280_36375f83-7e83-afcf-e063-6394a90aa789
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
Substance
METRONIDAZOLE
Active strength
500 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 formatDescriptionMarketing startSampleExclude flagStatus
68071-2280-4680712280044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2280-4) 2020-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metronidazole Tablets USPNuCare Pharmaceuticals,Inc.2025-05-28HUMAN PRESCRIPTION DRUG LABEL4