gadobutrol

Generic: gadobutrol

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gadobutrol
Generic Name gadobutrol
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadobutrol 604.72 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-289
Product ID 65219-289_d546f4fe-ebb3-47cf-9222-563d15caa8b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216081
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

Pharmacologic Class

Established (EPC)
gadolinium-based contrast agent [epc]
Mechanism of Action
magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219289
Hyphenated Format 65219-289

Supplemental Identifiers

UNII
1BJ477IO2L
NUI
N0000183362 N0000175862

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 gadobutrol (source: ndc)
Generic Name gadobutrol (source: ndc)
Application Number ANDA216081 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 604.72 mg/mL
source: ndc
Packaging
  • 10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10)
source: ndc

Packages (1)

65219-289-65 10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10)

Ingredients (1)

gadobutrol (604.72 mg/mL)

Linked Drug Pages (1)

Gadobutrol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d546f4fe-ebb3-47cf-9222-563d15caa8b1", "openfda": {"nui": ["N0000183362", "N0000175862"], "unii": ["1BJ477IO2L"], "spl_set_id": ["c0dd1618-0bb3-4974-846b-e5afc2311ae6"], "pharm_class_epc": ["Gadolinium-based Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE in 1 CARTON (65219-289-65)  / 65 mL in 1 BOTTLE (65219-289-10)", "package_ndc": "65219-289-65", "marketing_start_date": "20231001"}], "brand_name": "Gadobutrol", "product_id": "65219-289_d546f4fe-ebb3-47cf-9222-563d15caa8b1", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "65219-289", "generic_name": "Gadobutrol", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gadobutrol", "active_ingredients": [{"name": "GADOBUTROL", "strength": "604.72 mg/mL"}], "application_number": "ANDA216081", "marketing_category": "ANDA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}