gadavist

Generic: gadobutrol

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

Drug Facts

Product Profile

Brand Name gadavist
Generic Name gadobutrol
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadobutrol 604.72 mg/mL

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-325
Product ID 50419-325_a2fcf7c7-9b3b-4ab3-a142-2769bfd08e60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201277
Listing Expiration 2027-12-31
Marketing Start 2011-03-14

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 50419325
Hyphenated Format 50419-325

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 gadavist (source: ndc)
Generic Name gadobutrol (source: ndc)
Application Number NDA201277 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 604.72 mg/mL
source: ndc
Packaging
  • 2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE
  • 2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
  • 2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE
  • 5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS
  • 5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS
  • 5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS
  • 15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS
source: ndc

Packages (9)

50419-325-11 2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE 50419-325-12 2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 50419-325-13 2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE 50419-325-27 5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS 50419-325-28 5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS 50419-325-29 5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS 50419-325-37 15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE 50419-325-72 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE 50419-325-75 5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS

Ingredients (1)

gadobutrol (604.72 mg/mL)

Linked Drug Pages (3)

Gadavist ndc-match (0.9) Gadavist ndc-match (0.9) Gadavist ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a2fcf7c7-9b3b-4ab3-a142-2769bfd08e60", "openfda": {"nui": ["N0000183362", "N0000175862"], "unii": ["1BJ477IO2L"], "spl_set_id": ["3c5101a0-0c7e-4078-8dc3-a57beb9a0e92"], "pharm_class_epc": ["Gadolinium-based Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 BOX (50419-325-11)  / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-325-11", "marketing_start_date": "20110315"}, {"sample": false, "description": "2 CARTON in 1 BOX (50419-325-12)  / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-325-12", "marketing_start_date": "20110315"}, {"sample": false, "description": "2 CARTON in 1 BOX (50419-325-13)  / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-325-13", "marketing_start_date": "20110315"}, {"sample": false, "description": "5 SYRINGE, GLASS in 1 BOX (50419-325-27)  / 7.5 mL in 1 SYRINGE, GLASS", "package_ndc": "50419-325-27", "marketing_start_date": "20110315"}, {"sample": false, "description": "5 SYRINGE, GLASS in 1 BOX (50419-325-28)  / 10 mL in 1 SYRINGE, GLASS", "package_ndc": "50419-325-28", "marketing_start_date": "20110315"}, {"sample": false, "description": "5 SYRINGE, GLASS in 1 BOX (50419-325-29)  / 15 mL in 1 SYRINGE, GLASS", "package_ndc": "50419-325-29", "marketing_start_date": "20110315"}, {"sample": false, "description": "15 CARTON in 1 BOX (50419-325-37)  / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-325-37", "marketing_start_date": "20110315"}, {"sample": true, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50419-325-72", "marketing_start_date": "20110315"}, {"sample": true, "description": "5 SYRINGE, GLASS in 1 BOX (50419-325-75)  / 10 mL in 1 SYRINGE, GLASS", "package_ndc": "50419-325-75", "marketing_start_date": "20220512"}], "brand_name": "Gadavist", "product_id": "50419-325_a2fcf7c7-9b3b-4ab3-a142-2769bfd08e60", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "50419-325", "generic_name": "gadobutrol", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gadavist", "active_ingredients": [{"name": "GADOBUTROL", "strength": "604.72 mg/mL"}], "application_number": "NDA201277", "marketing_category": "NDA", "marketing_start_date": "20110314", "listing_expiration_date": "20271231"}