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 65219-281
Product ID 65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215061
Listing Expiration 2026-12-31
Marketing Start 2023-04-14

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 65219281
Hyphenated Format 65219-281

Supplemental Identifiers

UPC
0365219281023
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 ANDA215061 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 604.72 mg/mL
source: ndc
Packaging
  • 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)
  • 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)
  • 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)
  • 2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)
source: ndc

Packages (4)

65219-281-02 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00) 65219-281-07 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03) 65219-281-10 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08) 65219-281-15 2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)

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": "490c8c3e-3195-40af-8f34-40d8df2719c3", "openfda": {"nui": ["N0000183362", "N0000175862"], "upc": ["0365219281023"], "unii": ["1BJ477IO2L"], "spl_set_id": ["007696d0-4b62-4937-9640-4ad619504df4"], "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": "5 CARTON in 1 BOX (65219-281-02)  / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)", "package_ndc": "65219-281-02", "marketing_start_date": "20230414"}, {"sample": false, "description": "2 CARTON in 1 BOX (65219-281-07)  / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)", "package_ndc": "65219-281-07", "marketing_start_date": "20230414"}, {"sample": false, "description": "2 CARTON in 1 BOX (65219-281-10)  / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)", "package_ndc": "65219-281-10", "marketing_start_date": "20230414"}, {"sample": false, "description": "2 CARTON in 1 BOX (65219-281-15)  / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)", "package_ndc": "65219-281-15", "marketing_start_date": "20230414"}], "brand_name": "Gadobutrol", "product_id": "65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "65219-281", "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": "ANDA215061", "marketing_category": "ANDA", "marketing_start_date": "20230414", "listing_expiration_date": "20261231"}