metronidazole

Generic: metronidazole

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

metronidazole 500 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-1055
Product ID 0338-1055_3e7d4d73-778e-4e49-bd5b-2c70c5c92488
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018657
Listing Expiration 2026-12-31
Marketing Start 1981-12-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03381055
Hyphenated Format 0338-1055

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 NDA018657 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 24 BAG in 1 CARTON (0338-1055-48) / 100 mL in 1 BAG
source: ndc

Packages (1)

0338-1055-48 24 BAG in 1 CARTON (0338-1055-48) / 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": "3e7d4d73-778e-4e49-bd5b-2c70c5c92488", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311683"], "spl_set_id": ["d2112f37-5080-4a19-bcc3-6386b49abe1d"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CARTON (0338-1055-48)  / 100 mL in 1 BAG", "package_ndc": "0338-1055-48", "marketing_start_date": "19811224"}], "brand_name": "Metronidazole", "product_id": "0338-1055_3e7d4d73-778e-4e49-bd5b-2c70c5c92488", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "0338-1055", "generic_name": "Metronidazole", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/100mL"}], "application_number": "NDA018657", "marketing_category": "NDA", "marketing_start_date": "19811224", "listing_expiration_date": "20261231"}