nuvessa

Generic: metronidazole

Labeler: exeltis usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nuvessa
Generic Name metronidazole
Labeler exeltis usa, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

metronidazole 65 mg/5g

Manufacturer
Exeltis USA, Inc.

Identifiers & Regulatory

Product NDC 0642-7466
Product ID 0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205223
Listing Expiration 2026-12-31
Marketing Start 2018-03-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06427466
Hyphenated Format 0642-7466

Supplemental Identifiers

RxCUI
1604336 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 nuvessa (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number NDA205223 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 65 mg/5g
source: ndc
Packaging
  • 1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR
  • 1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR
source: ndc

Packages (2)

0642-7466-05 1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR 0642-7466-06 1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR

Ingredients (1)

metronidazole (65 mg/5g)

Linked Drug Pages (1)

Nuvessa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "09d13114-f228-f0bc-e063-6394a90a84f5", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["1604336", "1608253"], "spl_set_id": ["3b6ff39d-f84b-43b3-9b07-c0521c6d7968"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Exeltis USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 CARTON (0642-7466-05)  / 5 g in 1 APPLICATOR", "package_ndc": "0642-7466-05", "marketing_start_date": "20180310"}, {"sample": true, "description": "1 APPLICATOR in 1 CARTON (0642-7466-06)  / 5 g in 1 APPLICATOR", "package_ndc": "0642-7466-06", "marketing_start_date": "20180310"}], "brand_name": "Nuvessa", "product_id": "0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "0642-7466", "generic_name": "metronidazole", "labeler_name": "Exeltis USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nuvessa", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "65 mg/5g"}], "application_number": "NDA205223", "marketing_category": "NDA", "marketing_start_date": "20180310", "listing_expiration_date": "20261231"}