NDC 50419-325

Gadavist

Gadobutrol

Gadavist is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Gadobutrol.

Product ID50419-325_013e6a9e-d632-4b80-bce8-d10ef3157033
NDC50419-325
Product TypeHuman Prescription Drug
Proprietary NameGadavist
Generic NameGadobutrol
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-03-14
Marketing CategoryNDA / NDA
Application NumberNDA201277
Labeler NameBayer HealthCare Pharmaceuticals Inc.
Substance NameGADOBUTROL
Active Ingredient Strength605 mg/mL
Pharm ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50419-325-18

2 CARTON in 1 BOX (50419-325-18) > 5 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS
Marketing Start Date2011-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50419-325-29 [50419032529]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-91 [50419032591]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-14
Marketing End Date2011-03-25

NDC 50419-325-12 [50419032512]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-92 [50419032592]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-14
Marketing End Date2011-03-25

NDC 50419-325-28 [50419032528]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-90 [50419032590]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-14
Marketing End Date2011-03-25

NDC 50419-325-14 [50419032514]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-27 [50419032527]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-72 [50419032572]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15

NDC 50419-325-15 [50419032515]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-13 [50419032513]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-11 [50419032511]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

NDC 50419-325-37 [50419032537]

Gadavist INJECTION
Marketing CategoryNDA
Application NumberNDA201277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-15

Drug Details

Active Ingredients

IngredientStrength
GADOBUTROL604.72 mg/mL

OpenFDA Data

SPL SET ID:bd28560f-de4d-4140-874e-31df823f4dbb
Manufacturer
UNII

Pharmacological Class

  • Gadolinium-based Contrast Agent [EPC]
  • Magnetic Resonance Contrast Activity [MoA]

Trademark Results [Gadavist]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GADAVIST
GADAVIST
85239263 4132896 Live/Registered
BAYER INTELLECTUAL PROPERTY GMBH
2011-02-10

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