Gadavist - 50419-325-72 - (gadobutrol)

Alphabetical Index


Drug Information of Gadavist

Product NDC: 50419-325
Proprietary Name: Gadavist
Non Proprietary Name: gadobutrol
Active Ingredient(s): 604.72    mg/mL & nbsp;   gadobutrol
Administration Route(s): INTRAVENOUS
Dosage Form(s): INJECTION
Coding System: National Drug Codes(NDC)

Labeler Information of Gadavist

Product NDC: 50419-325
Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA201277
Marketing Category: NDA
Start Marketing Date: 20110314

Package Information of Gadavist

Package NDC: 50419-325-72
Package Description: 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) > 10 mL in 1 VIAL, SINGLE-DOSE

NDC Information of Gadavist

NDC Code 50419-325-72
Proprietary Name Gadavist
Package Description 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) > 10 mL in 1 VIAL, SINGLE-DOSE
Product NDC 50419-325
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name gadobutrol
Dosage Form Name INJECTION
Route Name INTRAVENOUS
Start Marketing Date 20110314
Marketing Category Name NDA
Labeler Name Bayer HealthCare Pharmaceuticals Inc.
Substance Name GADOBUTROL
Strength Number 604.72
Strength Unit mg/mL
Pharmaceutical Classes

Complete Information of Gadavist


General Information