FDA.reportPublic FDA data

MultiHance

Product NDC
0270-5164
11-digit product format
002705164
Labeler code
0270
Product ID
0270-5164_0e7d3da8-78fa-b4ae-4a43-15919e900ebe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadobenate dimeglumine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA021357
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
0270-5164-12MultiHance5 in 1 BOXINJECTION, SOLUTION520
0270-5164-12MultiHance5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION520
0270-5164-13MultiHance10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1020
0270-5164-13MultiHance5 in 1 BOXINJECTION, SOLUTION520
0270-5164-14MultiHance15 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1520
0270-5164-14MultiHance5 in 1 BOXINJECTION, SOLUTION520
0270-5164-15MultiHance20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2020
0270-5164-15MultiHance5 in 1 BOXINJECTION, SOLUTION520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-5164-12ML - Milliliter0270-5164baae5f6f-ec28-4a0f-ac2c-c1276ce29b1f12012-07-24
0270-5164-13ML - Milliliter0270-5164fc76d3c8-2438-437d-a71a-4a103c31baa612012-07-24
0270-5164-14ML - Milliliter0270-5164aafcca53-2b28-48d8-b86f-245b71b04c4f12012-07-24
0270-5164-15ML - Milliliter0270-5164888d02cc-f68b-47e1-b596-b4f4640d850412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gadobenate dimeglumineACTIVE INGREDIENT3Q6PPC19POMULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]5
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NMULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0270-5164MULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]20Current NDC, Legacy NDC, 8 package rows20250316_59077a3e-5f03-4342-ae24-856267545631.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0270-5164-12002705164125 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSE2004-11-230000-00-00NoNoCurrent
0270-5164-13002705164135 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSE2004-11-230000-00-00NoNoCurrent
0270-5164-14002705164145 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14) / 15 mL in 1 VIAL, SINGLE-DOSE2004-11-230000-00-00NoNoCurrent
0270-5164-15002705164155 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-15) / 20 mL in 1 VIAL, SINGLE-DOSE2004-11-230000-00-00NoNoCurrent