metronidazole

Generic: metronidazole

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler preferred pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8552
Product ID 68788-8552_86325864-b6c8-460a-ae9d-3ad7463fd1db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217128
Listing Expiration 2026-12-31
Marketing Start 2023-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888552
Hyphenated Format 68788-8552

Supplemental Identifiers

RxCUI
311678
UNII
140QMO216E
NUI
N0000175435 M0014907

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 ANDA217128 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68788-8552-4) / 45 g in 1 TUBE
source: ndc

Packages (1)

68788-8552-4 1 TUBE in 1 CARTON (68788-8552-4) / 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": "86325864-b6c8-460a-ae9d-3ad7463fd1db", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311678"], "spl_set_id": ["59e53582-244a-4e9d-b18e-75dddc6a5052"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68788-8552-4)  / 45 g in 1 TUBE", "package_ndc": "68788-8552-4", "marketing_start_date": "20231120"}], "brand_name": "Metronidazole", "product_id": "68788-8552_86325864-b6c8-460a-ae9d-3ad7463fd1db", "dosage_form": "CREAM", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68788-8552", "generic_name": "Metronidazole", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA217128", "marketing_category": "ANDA", "marketing_start_date": "20231120", "listing_expiration_date": "20261231"}