metronidazole

Generic: metronidazole

Labeler: method pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler method pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
Method Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 58657-933
Product ID 58657-933_3e7f0950-f2b2-fb6a-e063-6394a90a8a92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070772
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58657933
Hyphenated Format 58657-933

Supplemental Identifiers

RxCUI
311681 314106 2702348
UPC
0358657739560 0358657739010
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 ANDA070772 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (58657-933-01) / 1 TABLET in 1 BLISTER PACK (58657-933-10)
  • 50 BLISTER PACK in 1 CARTON (58657-933-05) / 1 TABLET in 1 BLISTER PACK (58657-933-10)
source: ndc

Packages (2)

58657-933-01 100 BLISTER PACK in 1 CARTON (58657-933-01) / 1 TABLET in 1 BLISTER PACK (58657-933-10) 58657-933-05 50 BLISTER PACK in 1 CARTON (58657-933-05) / 1 TABLET in 1 BLISTER PACK (58657-933-10)

Ingredients (1)

metronidazole (250 mg/1)

Linked Drug Pages (1)

metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e7f0950-f2b2-fb6a-e063-6394a90a8a92", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0358657739560", "0358657739010"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106", "2702348"], "spl_set_id": ["2ae49bf4-a23b-bdcc-e063-6294a90a80a9"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Method Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (58657-933-01)  / 1 TABLET in 1 BLISTER PACK (58657-933-10)", "package_ndc": "58657-933-01", "marketing_start_date": "20250701"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (58657-933-05)  / 1 TABLET in 1 BLISTER PACK (58657-933-10)", "package_ndc": "58657-933-05", "marketing_start_date": "20250701"}], "brand_name": "metronidazole", "product_id": "58657-933_3e7f0950-f2b2-fb6a-e063-6394a90a8a92", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "58657-933", "generic_name": "metronidazole", "labeler_name": "Method Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA070772", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}