metronidazole

Generic: metronidazole

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-664
Product ID 16571-664_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721
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 16571664
Hyphenated Format 16571-664

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 (16571-664-01)
  • 500 TABLET in 1 BOTTLE (16571-664-50)
source: ndc

Packages (2)

16571-664-01 100 TABLET in 1 BOTTLE (16571-664-01) 16571-664-50 500 TABLET in 1 BOTTLE (16571-664-50)

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": "241c7c4c-5fd9-4c0e-b7b7-4094f77e9721", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["93e4f174-4fe0-4cfd-a0cf-d0963e082107"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-664-01)", "package_ndc": "16571-664-01", "marketing_start_date": "20150529"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16571-664-50)", "package_ndc": "16571-664-50", "marketing_start_date": "20150529"}], "brand_name": "Metronidazole", "product_id": "16571-664_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "16571-664", "generic_name": "Metronidazole", "labeler_name": "Rising Pharma Holdings, Inc.", "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"}