metronidazole

Generic: metronidazole

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

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler oceanside pharmaceuticals
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-455
Product ID 68682-455_65a9e9bc-c5ac-401a-addf-2d83b0df83a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020208
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682455
Hyphenated Format 68682-455

Supplemental Identifiers

RxCUI
142046
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 NDA020208 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

68682-455-70 1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70) / 70 g in 1 TUBE, WITH APPLICATOR

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": ["VAGINAL"], "spl_id": "65a9e9bc-c5ac-401a-addf-2d83b0df83a8", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["526c226a-099b-4eb3-943d-c88b2763b2c1"], "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": "1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "68682-455-70", "marketing_start_date": "20150401"}], "brand_name": "Metronidazole", "product_id": "68682-455_65a9e9bc-c5ac-401a-addf-2d83b0df83a8", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68682-455", "generic_name": "metronidazole", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "NDA020208", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}