metronidazole

Generic: metronidazole

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

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

metronidazole 500 mg/100mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-373
Product ID 68083-373_537a76aa-6ca1-4f27-a672-725a7e22f81d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212435
Listing Expiration 2026-12-31
Marketing Start 2020-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083373
Hyphenated Format 68083-373

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 ANDA212435 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (68083-373-04) / 1 BAG in 1 POUCH (68083-373-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

68083-373-04 4 POUCH in 1 CARTON (68083-373-04) / 1 BAG in 1 POUCH (68083-373-01) / 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": "537a76aa-6ca1-4f27-a672-725a7e22f81d", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311683"], "spl_set_id": ["74cf111a-9b83-4f93-b0e8-bc252d471d43"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (68083-373-04)  / 1 BAG in 1 POUCH (68083-373-01)  / 100 mL in 1 BAG", "package_ndc": "68083-373-04", "marketing_start_date": "20200803"}], "brand_name": "Metronidazole", "product_id": "68083-373_537a76aa-6ca1-4f27-a672-725a7e22f81d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68083-373", "generic_name": "Metronidazole", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/100mL"}], "application_number": "ANDA212435", "marketing_category": "ANDA", "marketing_start_date": "20200803", "listing_expiration_date": "20261231"}