Metronidazole

Product NDC
50090-7160
11-digit product format
500907160
Labeler code
50090
Product ID
50090-7160_54ce71c2-b878-455c-83b0-70525d10695a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
A-S Medication Solutions
Application
ANDA215794
Marketing category
ANDA
Marketing start
2022-06-24
Substance
METRONIDAZOLE
Active strength
7.5 mg/g
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
50090-7160-0500907160001 TUBE, WITH APPLICATOR in 1 CARTON (50090-7160-0) / 70 g in 1 TUBE, WITH APPLICATOR2024-05-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metronidazole Vaginal Gel, 0.75%A-S Medication Solutions2024-05-06HUMAN PRESCRIPTION DRUG LABEL1