Metronidazole

Product NDC
70518-4495
11-digit product format
705184495
Labeler code
70518
Product ID
70518-4495_40cf73ed-a984-ec03-e063-6294a90a4e93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
REMEDYREPACK INC.
Application
ANDA213648
Marketing category
ANDA
Marketing start
2025-10-10
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
70518-4495-0705184495001 TUBE, WITH APPLICATOR in 1 CARTON (70518-4495-0) / 70 g in 1 TUBE, WITH APPLICATOR2025-10-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metronidazole Vaginal Gel, 0.75% FOR INTRAVAGINAL USE ONLY NOT FOR OPHTHALMIC, DERMAL, OR ORAL USEREMEDYREPACK INC.2025-10-10HUMAN PRESCRIPTION DRUG LABEL1