metronidazole

Product NDC
76420-800
11-digit product format
764200800
Labeler code
76420
Product ID
76420-800_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
250 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
76420-800-0176420080001100 TABLET in 1 BOTTLE (76420-800-01) 100 tablet2024-04-26NoNoHistorical
76420-800-0576420080005500 TABLET in 1 BOTTLE (76420-800-05) 500 tablet2024-04-26NoNoHistorical
76420-800-217642008002121 TABLET in 1 BOTTLE (76420-800-21) 21 tablet2024-04-26NoNoHistorical
76420-800-2576420080025250 TABLET in 1 BOTTLE (76420-800-25) 250 tablet2024-04-26NoNoHistorical
76420-800-307642008003030 TABLET in 1 BOTTLE (76420-800-30) 30 tablet2024-04-26NoNoHistorical
76420-800-607642008006060 TABLET in 1 BOTTLE (76420-800-60) 60 tablet2024-04-26NoNoHistorical
76420-800-907642008009090 TABLET in 1 BOTTLE (76420-800-90) 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