metronidazole

Generic: metronidazole

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler oceanside pharmaceuticals
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

metronidazole 10 mg/60g

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-202
Product ID 68682-202_0e74a7e8-92d3-4287-a130-b80624733587
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020743
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682202
Hyphenated Format 68682-202

Supplemental Identifiers

RxCUI
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 metronidazole (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
  • 60 g in 1 TUBE (68682-202-60)
source: ndc

Packages (1)

68682-202-60 60 g in 1 TUBE (68682-202-60)

Ingredients (1)

metronidazole (10 mg/60g)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0e74a7e8-92d3-4287-a130-b80624733587", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311680"], "spl_set_id": ["cdf2e251-4bbc-4434-9b00-bef6284491e4"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 g in 1 TUBE (68682-202-60)", "package_ndc": "68682-202-60", "marketing_start_date": "20230801"}], "brand_name": "Metronidazole", "product_id": "68682-202_0e74a7e8-92d3-4287-a130-b80624733587", "dosage_form": "CREAM", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68682-202", "generic_name": "metronidazole", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "10 mg/60g"}], "application_number": "NDA020743", "marketing_category": "NDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}