metronidazole

Generic: metronidazole

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-800
Product ID 76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206560
Listing Expiration 2026-12-31
Marketing Start 2019-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420800
Hyphenated Format 76420-800

Supplemental Identifiers

RxCUI
311681 314106
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 ANDA206560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-800-01)
  • 500 TABLET in 1 BOTTLE (76420-800-05)
  • 21 TABLET in 1 BOTTLE (76420-800-21)
  • 250 TABLET in 1 BOTTLE (76420-800-25)
  • 30 TABLET in 1 BOTTLE (76420-800-30)
  • 60 TABLET in 1 BOTTLE (76420-800-60)
  • 90 TABLET in 1 BOTTLE (76420-800-90)
source: ndc

Packages (7)

76420-800-01 100 TABLET in 1 BOTTLE (76420-800-01) 76420-800-05 500 TABLET in 1 BOTTLE (76420-800-05) 76420-800-21 21 TABLET in 1 BOTTLE (76420-800-21) 76420-800-25 250 TABLET in 1 BOTTLE (76420-800-25) 76420-800-30 30 TABLET in 1 BOTTLE (76420-800-30) 76420-800-60 60 TABLET in 1 BOTTLE (76420-800-60) 76420-800-90 90 TABLET in 1 BOTTLE (76420-800-90)

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": "174d0504-a4e2-2f2a-e063-6394a90a1390", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["89970965-a995-4ae4-a70b-bd2de38081e1"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-800-01)", "package_ndc": "76420-800-01", "marketing_start_date": "20240426"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-800-05)", "package_ndc": "76420-800-05", "marketing_start_date": "20240426"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (76420-800-21)", "package_ndc": "76420-800-21", "marketing_start_date": "20240426"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (76420-800-25)", "package_ndc": "76420-800-25", "marketing_start_date": "20240426"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-800-30)", "package_ndc": "76420-800-30", "marketing_start_date": "20240426"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-800-60)", "package_ndc": "76420-800-60", "marketing_start_date": "20240426"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-800-90)", "package_ndc": "76420-800-90", "marketing_start_date": "20240426"}], "brand_name": "metronidazole", "product_id": "76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "76420-800", "generic_name": "metronidazole", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA206560", "marketing_category": "ANDA", "marketing_start_date": "20190223", "listing_expiration_date": "20261231"}