metronidazole

Generic: metronidazole

Labeler: b. braun medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler b. braun medical inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

metronidazole 500 mg/100mL

Manufacturer
B. Braun Medical Inc.

Identifiers & Regulatory

Product NDC 0264-5535
Product ID 0264-5535_ff10d27d-6a3a-45db-ae74-72ba2f442dd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018900
Listing Expiration 2026-12-31
Marketing Start 1983-09-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02645535
Hyphenated Format 0264-5535

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 NDA018900 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 6 CARTON in 1 CASE (0264-5535-32) / 4 CONTAINER in 1 CARTON / 100 mL in 1 CONTAINER
source: ndc

Packages (1)

0264-5535-32 6 CARTON in 1 CASE (0264-5535-32) / 4 CONTAINER in 1 CARTON / 100 mL in 1 CONTAINER

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": "ff10d27d-6a3a-45db-ae74-72ba2f442dd6", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311683"], "spl_set_id": ["fd191c06-9d3b-4e46-9f79-90f6af614947"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["B. Braun Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CARTON in 1 CASE (0264-5535-32)  / 4 CONTAINER in 1 CARTON / 100 mL in 1 CONTAINER", "package_ndc": "0264-5535-32", "marketing_start_date": "19830929"}], "brand_name": "METRONIDAZOLE", "product_id": "0264-5535_ff10d27d-6a3a-45db-ae74-72ba2f442dd6", "dosage_form": "SOLUTION", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "0264-5535", "generic_name": "METRONIDAZOLE", "labeler_name": "B. Braun Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METRONIDAZOLE", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/100mL"}], "application_number": "NDA018900", "marketing_category": "NDA", "marketing_start_date": "19830929", "listing_expiration_date": "20261231"}