metronidazole

Generic: metronidazole

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-511
Product ID 63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070027
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187511
Hyphenated Format 63187-511

Supplemental Identifiers

RxCUI
314106
UPC
0363187511289
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 ANDA070027 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE (63187-511-14)
  • 21 TABLET in 1 BOTTLE (63187-511-21)
  • 28 TABLET in 1 BOTTLE (63187-511-28)
  • 30 TABLET in 1 BOTTLE (63187-511-30)
  • 60 TABLET in 1 BOTTLE (63187-511-60)
  • 90 TABLET in 1 BOTTLE (63187-511-90)
source: ndc

Packages (6)

63187-511-14 14 TABLET in 1 BOTTLE (63187-511-14) 63187-511-21 21 TABLET in 1 BOTTLE (63187-511-21) 63187-511-28 28 TABLET in 1 BOTTLE (63187-511-28) 63187-511-30 30 TABLET in 1 BOTTLE (63187-511-30) 63187-511-60 60 TABLET in 1 BOTTLE (63187-511-60) 63187-511-90 90 TABLET in 1 BOTTLE (63187-511-90)

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": "38b36dca-b8a7-4ade-8307-15ce185b643e", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0363187511289"], "unii": ["140QMO216E"], "rxcui": ["314106"], "spl_set_id": ["205054e1-8172-47dc-931c-a18a60e7e9f0"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE (63187-511-14)", "package_ndc": "63187-511-14", "marketing_start_date": "20210812"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (63187-511-21)", "package_ndc": "63187-511-21", "marketing_start_date": "20210812"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (63187-511-28)", "package_ndc": "63187-511-28", "marketing_start_date": "20210812"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-511-30)", "package_ndc": "63187-511-30", "marketing_start_date": "20210812"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-511-60)", "package_ndc": "63187-511-60", "marketing_start_date": "20210812"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-511-90)", "package_ndc": "63187-511-90", "marketing_start_date": "20210812"}], "brand_name": "Metronidazole", "product_id": "63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "63187-511", "generic_name": "Metronidazole", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA070027", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}