Home NDC 0270-5164-13 MultiHance
Product NDC 0270-5164
Requested package NDC 0270-5164-13
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 172 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 2026-09-14 22:38:34 2026-08 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021357-001 MULTIHANCE 2.645GM/5ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021357-002 MULTIHANCE 5.29GM/10ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021357-003 MULTIHANCE 7.935GM/15ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021357-004 MULTIHANCE 10.58GM/20ML (529MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2004-11-23 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 0270-5164-12 MultiHance 5 in 1 BOX INJECTION, SOLUTION 5 20 0270-5164-12 MultiHance 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 20 0270-5164-13 MultiHance 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 20 0270-5164-13 MultiHance 5 in 1 BOX INJECTION, SOLUTION 5 20 0270-5164-14 MultiHance 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 15 20 0270-5164-14 MultiHance 5 in 1 BOX INJECTION, SOLUTION 5 20 0270-5164-15 MultiHance 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 20 0270-5164-15 MultiHance 5 in 1 BOX INJECTION, SOLUTION 5 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-5164 MULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 20 Current NDC, Legacy NDC, 8 package rows 20250316_59077a3e-5f03-4342-ae24-856267545631.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0270-5164-13 00270516413 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSE 2004-11-23 0000-00-00 No No Current