FDA.reportPublic FDA data

gadobutrol

Product NDC
70436-214
11-digit product format
704360214
Labeler code
70436
Product ID
70436-214_3304f07e-e137-e806-e063-6394a90a8a4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadobutrol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA217480
Marketing category
ANDA
Marketing start
2023-10-20
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
3c495eba-e7eb-cf97-a376-25ae31b0cc54Product name120140508
51162ac0-9a99-d9a1-b417-523615d04171Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-214-34gadobutrol15 mL in 1 VIAL, SINGLE-DOSEINJECTION154
70436-214-54gadobutrol20 in 1 CARTONINJECTION204
70436-214-80gadobutrol1 in 1 CARTONINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-214-34ML - Milliliter70436-214f61fa5d8-3325-49bd-ba28-0c4a013a3d3112024-05-16
70436-214-54ML - Milliliter70436-214d5c1b130-20c1-4f8e-83f7-047e2d1d35bc12024-06-10
70436-214-80ML - Milliliter70436-21480bd7cf5-e026-4deb-805a-7e7cae69140f12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-214GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC]4Current NDC, 3 package rows20250419_832e0ae1-4fe1-4dff-9978-c9200bcebb55.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-214-347043602143415 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
70436-214-547043602145420 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-54) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34) 2023-10-20NoNoCurrent
70436-214-80704360214801 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34) 2023-10-20NoNoCurrent