FDA.reportPublic FDA data

Gadobutrol

Product NDC
65219-281
11-digit product format
652190281
Labeler code
65219
Product ID
65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gadobutrol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA215061
Marketing category
ANDA
Marketing start
2023-04-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gadobutrol
Listing expiration
2026-12-31

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3c495eba-e7eb-cf97-a376-25ae31b0cc54Product name120140508
51162ac0-9a99-d9a1-b417-523615d04171Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-281-00Gadobutrol2 mL in 1 VIAL, SINGLE-DOSEINJECTION23
65219-281-02Gadobutrol3 in 1 CARTONINJECTION33
65219-281-02Gadobutrol5 in 1 BOXINJECTION53
65219-281-03Gadobutrol7.5 mL in 1 VIAL, SINGLE-DOSEINJECTION7.53
65219-281-05Gadobutrol15 mL in 1 VIAL, SINGLE-DOSEINJECTION153
65219-281-07Gadobutrol10 in 1 CARTONINJECTION103
65219-281-07Gadobutrol2 in 1 BOXINJECTION23
65219-281-08Gadobutrol10 mL in 1 VIAL, SINGLE-DOSEINJECTION103
65219-281-10Gadobutrol10 in 1 CARTONINJECTION103
65219-281-10Gadobutrol2 in 1 BOXINJECTION23
65219-281-15Gadobutrol10 in 1 CARTONINJECTION103
65219-281-15Gadobutrol2 in 1 BOXINJECTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-281-00ML - Milliliter65219-281273c0413-88f9-4927-970f-5828015629a212023-08-08
65219-281-02ML - Milliliter65219-281940a2b60-1fab-41ce-82d4-15220f38969112023-08-08
65219-281-03ML - Milliliter65219-281a4279d8f-cf98-4527-b747-9e196c1844a412023-08-08
65219-281-05ML - Milliliter65219-28117da6f10-18c3-4d3d-bbae-3f715f703eb112023-08-08
65219-281-07ML - Milliliter65219-281b7d8a359-61db-4ded-a1e2-3c40eea22a5d12023-08-08
65219-281-08ML - Milliliter65219-2811d458f43-36a1-4389-b635-1a91762ba07812023-08-08
65219-281-10ML - Milliliter65219-28199027c20-79d7-4c70-bfa9-78ad46fc19ca12023-08-08
65219-281-15ML - Milliliter65219-2818980610e-44fb-43a8-8815-31a9866d08f012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-281GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC]2Current NDC, 12 package rows20250119_007696d0-4b62-4937-9640-4ad619504df4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-281-00652190281002 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
65219-281-02652190281025 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00) 5 carton2023-04-14NoNoCurrent
65219-281-03652190281037.5 mL in 1 VIAL, SINGLE-DOSE7.5 mlHistorical
65219-281-056521902810515 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
65219-281-07652190281072 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03) 2 carton2023-04-14NoNoCurrent
65219-281-086521902810810 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
65219-281-10652190281102 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08) 2 carton2023-04-14NoNoCurrent
65219-281-15652190281152 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05) 2 carton2023-04-14NoNoCurrent