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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0270-5164		D	Discontinued by firm	2026-08-10
excluded package	package	0270-5164	0270-5164-18	D	Discontinued by firm	2026-08-10
excluded package	package	0270-5164	0270-5164-19	D	Discontinued by firm	2026-08-10
excluded package	package	0270-5164	0270-5164-20	D	Discontinued by firm	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0270-5164-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0270-5164-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0270-5164-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0270-5164-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0270-5164-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0270-5164-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0270-5164-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0270-5164-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0270-5164-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0270-5164-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0270-5164-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0270-5164-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0270-5164-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0270-5164-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0270-5164-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0270-5164-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0270-5164-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0270-5164-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0270-5164-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0270-5164-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0270-5164-19	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0270-5164-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0270-5164-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0270-5164-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0270-5164-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0270-5164-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0270-5164-19	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0270-5164-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0270-5164-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0270-5164-19	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0270-5164-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0270-5164-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0270-5164-19	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0270-5164-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0270-5164-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0270-5164-19	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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	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…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
59077a3e-5f03-4342-ae24-856267545631	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5b2d15dc-225b-aca9-f9ef-b38666fe1e57	Product name	4	20250620
c34d3757-8380-f2a9-d77b-04fccc1c986e	Product name	4	20250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54	Product name	1	20140508
51162ac0-9a99-d9a1-b417-523615d04171	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0270-5164-12	ML - Milliliter	0270-5164	baae5f6f-ec28-4a0f-ac2c-c1276ce29b1f	1	2012-07-24
0270-5164-13	ML - Milliliter	0270-5164	fc76d3c8-2438-437d-a71a-4a103c31baa6	1	2012-07-24
0270-5164-14	ML - Milliliter	0270-5164	aafcca53-2b28-48d8-b86f-245b71b04c4f	1	2012-07-24
0270-5164-15	ML - Milliliter	0270-5164	888d02cc-f68b-47e1-b596-b4f4640d8504	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
gadobenate dimeglumine	ACTIVE INGREDIENT	3Q6PPC19PO	MULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	5
GADOLINIUM CATION (3+)	ACTIVE MOIETY	AZV954TZ9N	MULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	5

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.

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3Q6PPC19PO	GADOBENATE DIMEGLUMINE	127000-20-8	GADOBENATE DIMEGLUMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0270-5164-12	00270516412	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSE	2004-11-23	0000-00-00	No	No	Current
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
0270-5164-14	00270516414	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14) / 15 mL in 1 VIAL, SINGLE-DOSE	2004-11-23	0000-00-00	No	No	Current
0270-5164-15	00270516415	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-15) / 20 mL in 1 VIAL, SINGLE-DOSE	2004-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MultiHance	BRACCO DIAGNOSTICS INC \| BRACCO IMAGING SPA \| BIPSO GmbH \| Labor LS SE & Co. KG \| PATHEON ITALIA SPA \| BioChem Labor für biologishe und chemische	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	20