metronidazole

Generic: metronidazole

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-014
Product ID 82868-014_483491f2-bd96-dcd7-e063-6394a90a475d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206560
Listing Expiration 2027-12-31
Marketing Start 2023-09-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868014
Hyphenated Format 82868-014

Supplemental Identifiers

RxCUI
311681
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
  • 500 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE, PLASTIC (82868-014-14)
  • 20 TABLET in 1 BOTTLE, PLASTIC (82868-014-20)
  • 21 TABLET in 1 BOTTLE, PLASTIC (82868-014-21)
  • 28 TABLET in 1 BOTTLE, PLASTIC (82868-014-28)
  • 30 TABLET in 1 BOTTLE, PLASTIC (82868-014-30)
source: ndc

Packages (5)

82868-014-14 14 TABLET in 1 BOTTLE, PLASTIC (82868-014-14) 82868-014-20 20 TABLET in 1 BOTTLE, PLASTIC (82868-014-20) 82868-014-21 21 TABLET in 1 BOTTLE, PLASTIC (82868-014-21) 82868-014-28 28 TABLET in 1 BOTTLE, PLASTIC (82868-014-28) 82868-014-30 30 TABLET in 1 BOTTLE, PLASTIC (82868-014-30)

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": "483491f2-bd96-dcd7-e063-6394a90a475d", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["06bd4afb-4a45-294c-e063-6394a90a7ab1"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (82868-014-14)", "package_ndc": "82868-014-14", "marketing_start_date": "20230928"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (82868-014-20)", "package_ndc": "82868-014-20", "marketing_start_date": "20240812"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (82868-014-21)", "package_ndc": "82868-014-21", "marketing_start_date": "20240205"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (82868-014-28)", "package_ndc": "82868-014-28", "marketing_start_date": "20231004"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82868-014-30)", "package_ndc": "82868-014-30", "marketing_start_date": "20231130"}], "brand_name": "metronidazole", "product_id": "82868-014_483491f2-bd96-dcd7-e063-6394a90a475d", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "82868-014", "generic_name": "metronidazole", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA206560", "marketing_category": "ANDA", "marketing_start_date": "20230928", "listing_expiration_date": "20271231"}