MultiHance

Product NDC
0270-5264
11-digit product format
002705264
Labeler code
0270
Product ID
0270-5264_42adc803-ceea-22aa-459c-f8617b2d8e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadobenate dimeglumine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA021358
Marketing category
NDA
Marketing start
2004-11-23
Substance
GADOBENATE DIMEGLUMINE
Active strength
529 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
MultiHance
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOBENATE DIMEGLUMINE529 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3Q6PPC19PO

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
0270-5264-16MultiHance50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5022
0270-5264-16MultiHance5 in 1 BOXINJECTION, SOLUTION522
0270-5264-17MultiHance5 in 1 BOXINJECTION, SOLUTION522
0270-5264-17MultiHance100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-5264-16ML - Milliliter0270-52642341b2cf-0efe-49b7-91b9-9645fafab3b112012-07-24
0270-5264-17ML - Milliliter0270-5264a8a46591-db55-444e-ba6a-a88e86c3a80112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gadobenate dimeglumineACTIVE INGREDIENT3Q6PPC19POMULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]8
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NMULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0270-5264MULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]22Current NDC, Legacy NDC, 4 package rows20250321_f63abe56-46d9-4e32-afb1-f4e22370717d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0270-5264-16002705264165 BOTTLE, GLASS in 1 BOX (0270-5264-16) / 50 mL in 1 BOTTLE, GLASS2004-11-230000-00-00NoNoCurrent
0270-5264-17002705264175 BOTTLE, GLASS in 1 BOX (0270-5264-17) / 100 mL in 1 BOTTLE, GLASS2004-11-230000-00-00NoNoCurrent