Home Applications 021357 Application 021357
Type NDA
Sponsor BRACCO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MULTIHANCE GADOBENATE DIMEGLUMINE INJECTABLE;INTRAVENOUS 2.645GM/5ML (529MG/ML) Yes Yes 002 MULTIHANCE GADOBENATE DIMEGLUMINE INJECTABLE;INTRAVENOUS 5.29GM/10ML (529MG/ML) Yes Yes 003 MULTIHANCE GADOBENATE DIMEGLUMINE INJECTABLE;INTRAVENOUS 7.935GM/15ML (529MG/ML) Yes Yes 004 MULTIHANCE GADOBENATE DIMEGLUMINE INJECTABLE;INTRAVENOUS 10.58GM/20ML (529MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021357-001 MULTIHANCE GADOBENATE DIMEGLUMINE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 N021357-002 MULTIHANCE GADOBENATE DIMEGLUMINE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 N021357-003 MULTIHANCE GADOBENATE DIMEGLUMINE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 N021357-004 MULTIHANCE GADOBENATE DIMEGLUMINE 10.58GM/20ML (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 5 · 164 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 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 d06236e962d9…
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 59077a3e-5f03-4342-ae24-856267545631 2025-03-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021357 application number: NDA021357 ndc (product): 0270-5164
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0270-5164 MultiHance gadobenate dimeglumine BRACCO DIAGNOSTICS INC NDA Current 0270-5164 MultiHance gadobenate dimeglumine BRACCO DIAGNOSTICS INC NDA Current 0270-5164 MultiHance gadobenate dimeglumine BRACCO DIAGNOSTICS INC NDA Current 0270-5164 MultiHance gadobenate dimeglumine BRACCO DIAGNOSTICS INC NDA Current