metronidazole vaginal gel

Generic: metronidazole vaginal gel, 1.3 %

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

Drug Facts

Product Profile

Brand Name metronidazole vaginal gel
Generic Name metronidazole vaginal gel, 1.3 %
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 65 mg/5g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-046
Product ID 21922-046_fcf2dac3-2804-44d2-92ce-03c83220388c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216795
Listing Expiration 2026-12-31
Marketing Start 2024-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922046
Hyphenated Format 21922-046

Supplemental Identifiers

RxCUI
1608253
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 (source: ndc)
Generic Name metronidazole vaginal gel, 1.3 % (source: ndc)
Application Number ANDA216795 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 65 mg/5g
source: ndc
Packaging
  • 1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR
source: ndc

Packages (1)

21922-046-41 1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR

Ingredients (1)

metronidazole (65 mg/5g)

Linked Drug Pages (1)

Metronidazole Vaginal Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "fcf2dac3-2804-44d2-92ce-03c83220388c", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["1608253"], "spl_set_id": ["585d2553-e19f-4227-82db-e4c2034863bf"], "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 APPLICATOR in 1 CARTON (21922-046-41)  / 5 g in 1 APPLICATOR", "package_ndc": "21922-046-41", "marketing_start_date": "20240319"}], "brand_name": "Metronidazole Vaginal Gel", "product_id": "21922-046_fcf2dac3-2804-44d2-92ce-03c83220388c", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "21922-046", "generic_name": "Metronidazole vaginal gel, 1.3 %", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole Vaginal Gel", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "65 mg/5g"}], "application_number": "ANDA216795", "marketing_category": "ANDA", "marketing_start_date": "20240319", "listing_expiration_date": "20261231"}