gadobutrol

Generic: gadobutrol

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gadobutrol
Generic Name gadobutrol
Labeler slate run pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadobutrol 604.72 mg/mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-213
Product ID 70436-213_3304f07e-e137-e806-e063-6394a90a8a4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217480
Listing Expiration 2026-12-31
Marketing Start 2025-04-16

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 70436213
Hyphenated Format 70436-213

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 ANDA217480 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 604.72 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-213-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-213-33)
source: ndc

Packages (1)

70436-213-82 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-213-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-213-33)

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": "3304f07e-e137-e806-e063-6394a90a8a4a", "openfda": {"nui": ["N0000183362", "N0000175862"], "unii": ["1BJ477IO2L"], "spl_set_id": ["832e0ae1-4fe1-4dff-9978-c9200bcebb55"], "pharm_class_epc": ["Gadolinium-based Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-213-82)  / 10 mL in 1 VIAL, SINGLE-DOSE (70436-213-33)", "package_ndc": "70436-213-82", "marketing_start_date": "20250416"}], "brand_name": "gadobutrol", "product_id": "70436-213_3304f07e-e137-e806-e063-6394a90a8a4a", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "70436-213", "generic_name": "gadobutrol", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gadobutrol", "active_ingredients": [{"name": "GADOBUTROL", "strength": "604.72 mg/mL"}], "application_number": "ANDA217480", "marketing_category": "ANDA", "marketing_start_date": "20250416", "listing_expiration_date": "20261231"}