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, FILM COATED
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-827
Product ID 63187-827_dd1f4531-7376-4eb7-9da6-69c1444a9ec3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203458
Listing Expiration 2027-12-31
Marketing Start 2014-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187827
Hyphenated Format 63187-827

Supplemental Identifiers

RxCUI
311681
UPC
0363187827045
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
  • 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-04)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-14)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-21)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-30)
source: ndc

Packages (5)

63187-827-04 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-04) 63187-827-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-14) 63187-827-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-21) 63187-827-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-28) 63187-827-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-30)

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": "dd1f4531-7376-4eb7-9da6-69c1444a9ec3", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0363187827045"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["a56c2842-8ad4-4396-8eb6-cbcd1629fcb1"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-04)", "package_ndc": "63187-827-04", "marketing_start_date": "20170501"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-14)", "package_ndc": "63187-827-14", "marketing_start_date": "20140601"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-21)", "package_ndc": "63187-827-21", "marketing_start_date": "20140601"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-28)", "package_ndc": "63187-827-28", "marketing_start_date": "20260128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-30)", "package_ndc": "63187-827-30", "marketing_start_date": "20140601"}], "brand_name": "Metronidazole", "product_id": "63187-827_dd1f4531-7376-4eb7-9da6-69c1444a9ec3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "63187-827", "generic_name": "Metronidazole", "labeler_name": "Proficient Rx LP", "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": "20140601", "listing_expiration_date": "20271231"}