metronidazole

Generic: metronidazole

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler aurobindo pharma limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-770
Product ID 59651-770_0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219295
Listing Expiration 2026-12-31
Marketing Start 2025-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651770
Hyphenated Format 59651-770

Supplemental Identifiers

RxCUI
311678
UPC
0359651770467
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 ANDA219295 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (59651-770-46) / 45 g in 1 TUBE
source: ndc

Packages (1)

59651-770-46 1 TUBE in 1 CARTON (59651-770-46) / 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": "0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0359651770467"], "unii": ["140QMO216E"], "rxcui": ["311678"], "spl_set_id": ["0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (59651-770-46)  / 45 g in 1 TUBE", "package_ndc": "59651-770-46", "marketing_start_date": "20250709"}], "brand_name": "Metronidazole", "product_id": "59651-770_0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74", "dosage_form": "CREAM", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "59651-770", "generic_name": "Metronidazole", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA219295", "marketing_category": "ANDA", "marketing_start_date": "20250709", "listing_expiration_date": "20261231"}