metronidazole

Generic: metronidazole

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-695
Product ID 65862-695_f56928ba-4263-4212-ae2e-d89fcc7bea68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203974
Listing Expiration 2026-12-31
Marketing Start 2015-05-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862695
Hyphenated Format 65862-695

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 ANDA203974 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-695-01)
  • 500 TABLET in 1 BOTTLE (65862-695-05)
  • 50 TABLET in 1 BOTTLE (65862-695-50)
  • 1000 TABLET in 1 BOTTLE (65862-695-99)
source: ndc

Packages (4)

65862-695-01 100 TABLET in 1 BOTTLE (65862-695-01) 65862-695-05 500 TABLET in 1 BOTTLE (65862-695-05) 65862-695-50 50 TABLET in 1 BOTTLE (65862-695-50) 65862-695-99 1000 TABLET in 1 BOTTLE (65862-695-99)

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": "f56928ba-4263-4212-ae2e-d89fcc7bea68", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["f68397ee-67db-472e-8607-4300064e37df"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-695-01)", "package_ndc": "65862-695-01", "marketing_start_date": "20150529"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-695-05)", "package_ndc": "65862-695-05", "marketing_start_date": "20150529"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (65862-695-50)", "package_ndc": "65862-695-50", "marketing_start_date": "20150529"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-695-99)", "package_ndc": "65862-695-99", "marketing_start_date": "20150529"}], "brand_name": "Metronidazole", "product_id": "65862-695_f56928ba-4263-4212-ae2e-d89fcc7bea68", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "65862-695", "generic_name": "Metronidazole", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA203974", "marketing_category": "ANDA", "marketing_start_date": "20150529", "listing_expiration_date": "20261231"}