metronidazole

Generic: metronidazole

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler zydus lifesciences limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1834
Product ID 70771-1834_bac9d2c8-3d87-4ec8-aa22-760d3c66440b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217128
Listing Expiration 2026-12-31
Marketing Start 2023-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711834
Hyphenated Format 70771-1834

Supplemental Identifiers

RxCUI
311678
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 ANDA217128 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (70771-1834-4) / 45 g in 1 TUBE
source: ndc

Packages (1)

70771-1834-4 1 TUBE in 1 CARTON (70771-1834-4) / 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": "bac9d2c8-3d87-4ec8-aa22-760d3c66440b", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311678"], "spl_set_id": ["728ebe6d-7a20-481d-845a-ceffa450179f"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (70771-1834-4)  / 45 g in 1 TUBE", "package_ndc": "70771-1834-4", "marketing_start_date": "20230531"}], "brand_name": "Metronidazole", "product_id": "70771-1834_bac9d2c8-3d87-4ec8-aa22-760d3c66440b", "dosage_form": "CREAM", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "70771-1834", "generic_name": "Metronidazole", "labeler_name": "Zydus Lifesciences Limited", "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": "20230531", "listing_expiration_date": "20261231"}