metronidazole

Generic: metronidazole topical

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

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole topical
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-070
Product ID 21922-070_a0c70ee2-3ac6-4610-8592-642fd2d1aafc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077547
Listing Expiration 2026-12-31
Marketing Start 2025-01-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922070
Hyphenated Format 21922-070

Supplemental Identifiers

RxCUI
311679
UPC
0321922070064
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 (source: ndc)
Generic Name metronidazole topical (source: ndc)
Application Number ANDA077547 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-070-06) / 45 g in 1 TUBE
source: ndc

Packages (1)

21922-070-06 1 TUBE in 1 CARTON (21922-070-06) / 45 g in 1 TUBE

Ingredients (1)

metronidazole (7.5 mg/g)

Linked Drug Pages (1)

METRONIDAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a0c70ee2-3ac6-4610-8592-642fd2d1aafc", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0321922070064"], "unii": ["140QMO216E"], "rxcui": ["311679"], "spl_set_id": ["05707735-e676-412a-9a77-ebd003afb16c"], "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 in 1 CARTON (21922-070-06)  / 45 g in 1 TUBE", "package_ndc": "21922-070-06", "marketing_start_date": "20250128"}], "brand_name": "METRONIDAZOLE", "product_id": "21922-070_a0c70ee2-3ac6-4610-8592-642fd2d1aafc", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "21922-070", "generic_name": "Metronidazole Topical", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METRONIDAZOLE", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA077547", "marketing_category": "ANDA", "marketing_start_date": "20250128", "listing_expiration_date": "20261231"}