metronidazole

Generic: metronidazole

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler bluepoint laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-365
Product ID 68001-365_4b804edc-dbaf-1ac9-e063-6394a90ab9f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203458
Listing Expiration 2027-12-31
Marketing Start 2018-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001365
Hyphenated Format 68001-365

Supplemental Identifiers

RxCUI
311681 314106
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 ANDA203458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-365-00)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-365-03)
source: ndc

Packages (2)

68001-365-00 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-365-00) 68001-365-03 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-365-03)

Ingredients (1)

metronidazole (500 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": "4b804edc-dbaf-1ac9-e063-6394a90ab9f2", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["3cf021b6-5794-4a86-b09d-bece0ba8b302"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-365-00)", "package_ndc": "68001-365-00", "marketing_start_date": "20180801"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-365-03)", "package_ndc": "68001-365-03", "marketing_start_date": "20180801"}], "brand_name": "Metronidazole", "product_id": "68001-365_4b804edc-dbaf-1ac9-e063-6394a90ab9f2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68001-365", "generic_name": "Metronidazole", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA203458", "marketing_category": "ANDA", "marketing_start_date": "20180801", "listing_expiration_date": "20271231"}