eovist

Generic: gadoxetate disodium

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eovist
Generic Name gadoxetate disodium
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gadoxetate disodium 181.43 mg/mL

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-320
Product ID 50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022090
Listing Expiration 2027-12-31
Marketing Start 2008-07-03

Pharmacologic Class

Classes
gadolinium-based contrast agent [epc] magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419320
Hyphenated Format 50419-320

Supplemental Identifiers

UNII
HOY74VZE0M

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 eovist (source: ndc)
Generic Name gadoxetate disodium (source: ndc)
Application Number NDA022090 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 181.43 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

50419-320-05 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE 50419-320-15 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE 50419-320-75 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gadoxetate disodium (181.43 mg/mL)

Linked Drug Pages (1)

EOVIST ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "21b68b8a-33ca-4b8a-9981-bb52c48674c2", "openfda": {"unii": ["HOY74VZE0M"], "spl_set_id": ["6218b1e1-cbc3-4c14-bec7-528ac163a561"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-320-05", "marketing_start_date": "20080703"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-320-15", "marketing_start_date": "20080703"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-320-75", "marketing_start_date": "20080703"}], "brand_name": "EOVIST", "product_id": "50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "50419-320", "generic_name": "Gadoxetate Disodium", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EOVIST", "active_ingredients": [{"name": "GADOXETATE DISODIUM", "strength": "181.43 mg/mL"}], "application_number": "NDA022090", "marketing_category": "NDA", "marketing_start_date": "20080703", "listing_expiration_date": "20271231"}