metronidazole

Generic: metronidazole

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0058
Product ID 70518-0058_47e1c5f2-aa4f-ae7e-e063-6294a90abf33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203458
Listing Expiration 2027-12-31
Marketing Start 2016-12-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705180058
Hyphenated Format 70518-0058

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
  • 14 TABLET, FILM COATED in 1 BOTTLE (70518-0058-0)
  • 4 TABLET, FILM COATED in 1 BOTTLE (70518-0058-1)
source: ndc

Packages (2)

70518-0058-0 14 TABLET, FILM COATED in 1 BOTTLE (70518-0058-0) 70518-0058-1 4 TABLET, FILM COATED in 1 BOTTLE (70518-0058-1)

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": "47e1c5f2-aa4f-ae7e-e063-6294a90abf33", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["49bed450-7fa8-401c-8c8c-afc1c61d473a"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (70518-0058-0)", "package_ndc": "70518-0058-0", "marketing_start_date": "20161213"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (70518-0058-1)", "package_ndc": "70518-0058-1", "marketing_start_date": "20170110"}], "brand_name": "Metronidazole", "product_id": "70518-0058_47e1c5f2-aa4f-ae7e-e063-6294a90abf33", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "70518-0058", "generic_name": "Metronidazole", "labeler_name": "REMEDYREPACK INC.", "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": "20161213", "listing_expiration_date": "20271231"}