metronidazole vaginal gel, 0.75%

Generic: metronidazole

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole vaginal gel, 0.75%
Generic Name metronidazole
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-039
Product ID 21922-039_15d347d5-e345-4750-9f5e-6c2b4f9c583a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215610
Listing Expiration 2026-12-31
Marketing Start 2023-06-17

Pharmacologic Class

Established (EPC)
nitroimidazole antimicrobial [epc]
Chemical Structure
nitroimidazoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922039
Hyphenated Format 21922-039

Supplemental Identifiers

RxCUI
142046
UPC
0321922039238
UNII
140QMO216E
NUI
N0000175435 M0014907

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name metronidazole vaginal gel, 0.75% (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number ANDA215610 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (21922-039-23) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

21922-039-23 1 TUBE, WITH APPLICATOR in 1 CARTON (21922-039-23) / 70 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

metronidazole (7.5 mg/g)

Linked Drug Pages (1)

Metronidazole Vaginal Gel, 0.75% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "15d347d5-e345-4750-9f5e-6c2b4f9c583a", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0321922039238"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["63ed1e7e-d264-4e35-af83-ec37fa5b06d1"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (21922-039-23)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "21922-039-23", "marketing_start_date": "20230617"}], "brand_name": "Metronidazole Vaginal Gel, 0.75%", "product_id": "21922-039_15d347d5-e345-4750-9f5e-6c2b4f9c583a", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "21922-039", "generic_name": "Metronidazole", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole Vaginal Gel, 0.75%", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA215610", "marketing_category": "ANDA", "marketing_start_date": "20230617", "listing_expiration_date": "20261231"}