metronidazole

Product NDC
76420-801
11-digit product format
764200801
Labeler code
76420
Product ID
76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA206560
Marketing category
ANDA
Marketing start
2019-02-23
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-801-0176420080101100 TABLET in 1 BOTTLE (76420-801-01) 100 tablet2024-04-26NoNoHistorical
76420-801-0576420080105500 TABLET in 1 BOTTLE (76420-801-05) 500 tablet2024-04-26NoNoHistorical
76420-801-217642008012121 TABLET in 1 BOTTLE (76420-801-21) 21 tablet2024-04-26NoNoHistorical
76420-801-307642008013030 TABLET in 1 BOTTLE (76420-801-30) 30 tablet2024-04-26NoNoHistorical
76420-801-507642008015050 TABLET in 1 BOTTLE (76420-801-50) 50 tablet2024-04-26NoNoHistorical
76420-801-607642008016060 TABLET in 1 BOTTLE (76420-801-60) 60 tablet2024-04-26NoNoHistorical
76420-801-907642008019090 TABLET in 1 BOTTLE (76420-801-90) 90 tablet2024-04-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metronidazole Tablets, USP Rx onlyAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-04-26HUMAN PRESCRIPTION DRUG LABEL1