noritate

Generic: metronidazole

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name noritate
Generic Name metronidazole
Labeler bausch health us, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

metronidazole 10 mg/60g

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-5202
Product ID 0187-5202_453f532e-bb72-4ea7-b9e5-b9ac903ffafe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020743
Listing Expiration 2026-12-31
Marketing Start 2013-08-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01875202
Hyphenated Format 0187-5202

Supplemental Identifiers

RxCUI
213120 311680
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 noritate (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number NDA020743 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/60g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBE
source: ndc

Packages (1)

0187-5202-60 1 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBE

Ingredients (1)

metronidazole (10 mg/60g)

Linked Drug Pages (1)

Noritate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "453f532e-bb72-4ea7-b9e5-b9ac903ffafe", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["213120", "311680"], "spl_set_id": ["706b09da-6cf9-421d-8e91-f3999474d322"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0187-5202-60)  / 60 g in 1 TUBE", "package_ndc": "0187-5202-60", "marketing_start_date": "20130908"}], "brand_name": "Noritate", "product_id": "0187-5202_453f532e-bb72-4ea7-b9e5-b9ac903ffafe", "dosage_form": "CREAM", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "0187-5202", "generic_name": "metronidazole", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Noritate", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "10 mg/60g"}], "application_number": "NDA020743", "marketing_category": "NDA", "marketing_start_date": "20130809", "listing_expiration_date": "20261231"}