FDA.reportPublic FDA data

Gadavist

Product NDC
50419-325
11-digit product format
504190325
Labeler code
50419
Product ID
50419-325_355ebf0b-3a4b-428a-90c2-38aa38308f03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadobutrol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA201277
Marketing category
NDA
Marketing start
2011-03-14
Substance
GADOBUTROL
Active strength
604.72 mg/mL
Pharmacologic classes
Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gadavist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOBUTROL604.72 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1BJ477IO2L

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
5b2d15dc-225b-aca9-f9ef-b38666fe1e57Product name420250620
c34d3757-8380-f2a9-d77b-04fccc1c986eProduct name420250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54Product name120140508
51162ac0-9a99-d9a1-b417-523615d04171Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50419-325-112024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-112024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-122024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-122024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-132024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-132024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-142024-01-30C16284748780-11030e365-0b0a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-142024-01-30C16284748780-11030e365-0b0a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-152024-01-30C16284748780-11030e365-0b0a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-152024-01-30C16284748780-11030e365-0b0a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-182024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-182024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-192024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-192024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-272024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-272024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-282024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-282024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-292024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-292024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-372024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-372024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-722024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-722024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-732024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-732024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-742024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-742024-01-30C16284748780-11030e365-5d93-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-752024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-752024-01-30C16284748780-11030e365-32fa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-325-11Gadavist2 in 1 BOXINJECTION226
50419-325-11Gadavist10 in 1 CARTONINJECTION1026
50419-325-12Gadavist10 in 1 CARTONINJECTION1026
50419-325-12Gadavist2 in 1 BOXINJECTION226
50419-325-13Gadavist10 in 1 CARTONINJECTION1026
50419-325-13Gadavist2 in 1 BOXINJECTION226
50419-325-27Gadavist5 in 1 BOXINJECTION526
50419-325-27Gadavist7.5 mL in 1 SYRINGE, GLASSINJECTION7.526
50419-325-28Gadavist5 in 1 BOXINJECTION526
50419-325-28Gadavist10 mL in 1 SYRINGE, GLASSINJECTION1026
50419-325-29Gadavist5 in 1 BOXINJECTION526
50419-325-29Gadavist15 mL in 1 SYRINGE, GLASSINJECTION1526
50419-325-37Gadavist3 in 1 CARTONINJECTION326
50419-325-37Gadavist15 in 1 BOXINJECTION1526
50419-325-72Gadavist10 mL in 1 VIAL, SINGLE-DOSEINJECTION1026
50419-325-72Gadavist10 in 1 CARTONINJECTION1026
50419-325-75Gadavist10 mL in 1 SYRINGE, GLASSINJECTION1026
50419-325-75Gadavist5 in 1 BOXINJECTION526
50419-325-14Gadavist5 in 1 CARTONINJECTION523
50419-325-14Gadavist2 in 1 BOXINJECTION223
50419-325-15Gadavist65 mL in 1 BOTTLE, GLASSINJECTION6523
50419-325-15Gadavist10 in 1 BOXINJECTION1023
50419-325-18Gadavist5 in 1 CARTONINJECTION513
50419-325-18Gadavist2 in 1 BOXINJECTION213
50419-325-19Gadavist65 mL in 1 BOTTLE, GLASSINJECTION6513
50419-325-19Gadavist10 in 1 BOXINJECTION1013
50419-325-73Gadavist30 mL in 1 BOTTLE, GLASSINJECTION3013
50419-325-74Gadavist65 mL in 1 BOTTLE, GLASSINJECTION6513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-325-11ML - Milliliter50419-325ca4f5f25-f969-495c-8e99-f6cb688f32ef12012-07-24
50419-325-12ML - Milliliter50419-325b8287ea2-08fe-4e05-81b5-f31b9e22766712012-07-24
50419-325-13ML - Milliliter50419-32575fa5a9a-4166-4540-9e8e-623b41b15dd212012-07-24
50419-325-14ML - Milliliter50419-3258457ebda-56c9-4f0e-a2ae-39f67669d41512012-07-24
50419-325-15ML - Milliliter50419-3257b0376e9-6179-4212-99c6-56ffc45e1f1012012-07-24
50419-325-27ML - Milliliter50419-325891bffd8-b289-463f-8407-8b546a0faaf212012-07-24
50419-325-28ML - Milliliter50419-32556bd2db9-dd1d-41f9-b5af-5bed59ea9a3b12012-07-24
50419-325-29ML - Milliliter50419-325092078fd-f287-45f1-b849-1d75bd1d70b012012-07-24
50419-325-37ML - Milliliter50419-325504636ea-956d-4820-a68d-6b7493412fc812014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GADOBUTROLACTIVE INGREDIENT1BJ477IO2LGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
GADOBUTROLACTIVE INGREDIENT1BJ477IO2LGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]6
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]6
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RGADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-325GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]24Current NDC, Legacy NDC, 18 package rows20250328_3c5101a0-0c7e-4078-8dc3-a57beb9a0e92.zip
50419-325GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 4 package rows20250328_bd28560f-de4d-4140-874e-31df823f4dbb.zip
50419-325GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 6 package rows20250328_b7afe34d-b70f-41a5-b89c-561bdf29f046.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-325-11504190325112 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE2 carton2011-03-150000-00-00NoNoCurrent
50419-325-12504190325122 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE2 carton2011-03-150000-00-00NoNoCurrent
50419-325-13504190325132 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE2 carton2011-03-150000-00-00NoNoCurrent
50419-325-14504190325142 CARTON in 1 BOX (50419-325-14) > 5 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS2 carton2011-03-152026-01-31NoNoCurrent
50419-325-155041903251510 BOTTLE, GLASS in 1 BOX (50419-325-15) > 65 mL in 1 BOTTLE, GLASS2011-03-150000-00-00NoNoCurrent
50419-325-18504190325182 CARTON in 1 BOX (50419-325-18) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS2 carton2011-03-150000-00-00NoNoCurrent
50419-325-195041903251910 BOTTLE, GLASS in 1 BOX (50419-325-19) / 65 mL in 1 BOTTLE, GLASS2011-03-150000-00-00NoNoCurrent
50419-325-27504190325275 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS2011-03-150000-00-00NoNoCurrent
50419-325-28504190325285 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS2011-03-150000-00-00NoNoCurrent
50419-325-29504190325295 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS2011-03-150000-00-00NoNoCurrent
50419-325-375041903253715 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE15 carton2011-03-150000-00-00NoNoCurrent
50419-325-725041903257210 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE2011-03-150000-00-00YesNoCurrent
50419-325-735041903257330 mL in 1 BOTTLE, GLASS (50419-325-73) 30 ml2021-02-110000-00-00NoNoCurrent
50419-325-745041903257465 mL in 1 BOTTLE, GLASS (50419-325-74) 65 ml2021-02-110000-00-00NoNoCurrent
50419-325-75504190325755 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS2022-05-120000-00-00YesNoCurrent