metronidazole

Generic: metronidazole

Labeler: amneal pharmaceuticals private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler amneal pharmaceuticals private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

metronidazole 500 mg/100mL

Manufacturer
Amneal Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 80830-2465
Product ID 80830-2465_ef0abec7-d5c4-4de2-8474-f16006304101
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217665
Listing Expiration 2026-12-31
Marketing Start 2023-06-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 808302465
Hyphenated Format 80830-2465

Supplemental Identifiers

RxCUI
311683
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 ANDA217665 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 24 POUCH in 1 CARTON (80830-2465-9) / 1 BAG in 1 POUCH (80830-2465-1) / 100 mL in 1 BAG
source: ndc

Packages (1)

80830-2465-9 24 POUCH in 1 CARTON (80830-2465-9) / 1 BAG in 1 POUCH (80830-2465-1) / 100 mL in 1 BAG

Ingredients (1)

metronidazole (500 mg/100mL)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ef0abec7-d5c4-4de2-8474-f16006304101", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311683"], "spl_set_id": ["843447a5-525c-48ea-860a-230db549fecb"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CARTON (80830-2465-9)  / 1 BAG in 1 POUCH (80830-2465-1)  / 100 mL in 1 BAG", "package_ndc": "80830-2465-9", "marketing_start_date": "20230617"}], "brand_name": "Metronidazole", "product_id": "80830-2465_ef0abec7-d5c4-4de2-8474-f16006304101", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "80830-2465", "generic_name": "Metronidazole", "labeler_name": "Amneal Pharmaceuticals Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/100mL"}], "application_number": "ANDA217665", "marketing_category": "ANDA", "marketing_start_date": "20230617", "listing_expiration_date": "20261231"}