Home NDC 0270-5264 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021358-001 MULTIHANCE MULTIPACK GADOBENATE DIMEGLUMINE 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 N021358-002 MULTIHANCE MULTIPACK GADOBENATE DIMEGLUMINE 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021358-001 MULTIHANCE MULTIPACK 26.45GM/50ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021358-002 MULTIHANCE MULTIPACK 52.9GM/100ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base MultiHance
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOBENATE DIMEGLUMINE 529 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3Q6PPC19PO Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0270-5264-16 MultiHance 50 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 50 22 0270-5264-16 MultiHance 5 in 1 BOX INJECTION, SOLUTION 5 22 0270-5264-17 MultiHance 5 in 1 BOX INJECTION, SOLUTION 5 22 0270-5264-17 MultiHance 100 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 100 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-5264 MULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 22 Current NDC, Legacy NDC, 4 package rows 20250321_f63abe56-46d9-4e32-afb1-f4e22370717d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MultiHance GADOBENATE DIMEGLUMINE BRACCO DIAGNOSTICS INC f63abe56-46d9-4e32-afb1-f4e22370717d 2025-03-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021358 application number: NDA021358 ndc (product): 0270-5264
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0270-5264-16 00270526416 5 BOTTLE, GLASS in 1 BOX (0270-5264-16) / 50 mL in 1 BOTTLE, GLASS 2004-11-23 0000-00-00 No No Current 0270-5264-17 00270526417 5 BOTTLE, GLASS in 1 BOX (0270-5264-17) / 100 mL in 1 BOTTLE, GLASS 2004-11-23 0000-00-00 No No Current