prohance

Generic: gadoteridol

Labeler: bracco diagnostics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prohance
Generic Name gadoteridol
Labeler bracco diagnostics inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gadoteridol 279.3 mg/mL

Manufacturer
Bracco Diagnostics Inc

Identifiers & Regulatory

Product NDC 0270-1111
Product ID 0270-1111_ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021489
Listing Expiration 2026-12-31
Marketing Start 2003-10-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02701111
Hyphenated Format 0270-1111

Supplemental Identifiers

UNII
0199MV609F
NUI
N0000175862 N0000180184

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 prohance (source: ndc)
Generic Name gadoteridol (source: ndc)
Application Number NDA021489 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 279.3 mg/mL
source: ndc
Packaging
  • 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (2)

0270-1111-70 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 0270-1111-85 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (1)

gadoteridol (279.3 mg/mL)

Linked Drug Pages (2)

ProHance ndc-match (0.9) ProHance ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2", "openfda": {"nui": ["N0000175862", "N0000180184"], "unii": ["0199MV609F"], "spl_set_id": ["e8b76200-c0aa-491b-aad7-e22d2f68496f"], "pharm_class_epc": ["Paramagnetic Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Bracco Diagnostics Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "0270-1111-70", "marketing_start_date": "20031009"}, {"sample": false, "description": "5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "0270-1111-85", "marketing_start_date": "20220201"}], "brand_name": "ProHance", "product_id": "0270-1111_ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Magnetic Resonance Contrast Activity [MoA]", "Paramagnetic Contrast Agent [EPC]"], "product_ndc": "0270-1111", "generic_name": "gadoteridol", "labeler_name": "Bracco Diagnostics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ProHance", "active_ingredients": [{"name": "GADOTERIDOL", "strength": "279.3 mg/mL"}], "application_number": "NDA021489", "marketing_category": "NDA", "marketing_start_date": "20031009", "listing_expiration_date": "20261231"}