metronidazole

Generic: metronidazole

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metronidazole 500 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-032
Product ID 61919-032_47e13e06-0078-1557-e063-6294a90a5f79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203458
Listing Expiration 2027-12-31
Marketing Start 2019-08-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919032
Hyphenated Format 61919-032

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 ANDA203458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (61919-032-10)
source: ndc

Packages (1)

61919-032-10 10 TABLET, FILM COATED in 1 BOTTLE (61919-032-10)

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": "47e13e06-0078-1557-e063-6294a90a5f79", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["90a5acb3-f8cc-1e82-e053-2995a90a4e97"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (61919-032-10)", "package_ndc": "61919-032-10", "marketing_start_date": "20190821"}], "brand_name": "METRONIDAZOLE", "product_id": "61919-032_47e13e06-0078-1557-e063-6294a90a5f79", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "61919-032", "generic_name": "METRONIDAZOLE", "labeler_name": "Direct_Rx", "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": "20190821", "listing_expiration_date": "20271231"}