Gadobutrol

Product NDC: 65219-287
11-digit product format: 652190287
Labeler code: 65219
Product ID: 65219-287_d546f4fe-ebb3-47cf-9222-563d15caa8b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gadobutrol
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA216081
Marketing category: ANDA
Marketing start: 2023-10-01
Substance: GADOBUTROL
Active strength: 604.72 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216081-001	GADOBUTROL	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08
A216081-002	GADOBUTROL	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08
A216081-003	GADOBUTROL	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17
A216081-004	GADOBUTROL	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17
A216081-005	GADOBUTROL	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17
A216081-006	GADOBUTROL	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216081-001	AP
A216081-002	AP

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216081-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216081-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-004	AP	1	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-001	CGT	2024-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-002	CGT	2024-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-001	CGT	2024-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-002	CGT	2024-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216081-001	CGT	2024-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216081-002	CGT	2024-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216081-001	CGT	2024-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216081-002	CGT	2024-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216081-001	CGT	2024-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216081-002	CGT	2024-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216081-001	CGT	2024-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216081-002	CGT	2024-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216081-001	CGT	2024-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216081-002	CGT	2024-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216081-001	CGT	2024-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216081-002	CGT	2024-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216081-001	CGT	2024-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216081-002	CGT	2024-04-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216081-001	CGT	2024-04-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216081-002	CGT	2024-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216081-001	CGT	2024-04-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216081-002	CGT	2024-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216081-001	CGT	2024-04-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216081-002	CGT	2024-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216081-001	CGT	2024-04-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216081-002	CGT	2024-04-29	`a72a2bbeb626…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gadobutrol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GADOBUTROL	604.72 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1BJ477IO2L	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
c0dd1618-0bb3-4974-846b-e5afc2311ae6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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	Strength	SPL version
65219-287-10	Gadobutrol	30 mL in 1 BOTTLE	INJECTION	30		4
65219-287-30	Gadobutrol	10 in 1 CARTON	INJECTION	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-287	GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC]	2	Current NDC, 2 package rows	20250119_c0dd1618-0bb3-4974-846b-e5afc2311ae6.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
Gadobutrol	GADOBUTROL	Fresenius Kabi USA, LLC	c0dd1618-0bb3-4974-846b-e5afc2311ae6	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216081 application number: ANDA216081 ndc (product): 65219-287

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1BJ477IO2L	GADOBUTROL	770691-21-9	GADOBUTROL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65219-287-10	65219028710	30 mL in 1 BOTTLE	30 ml				Historical
65219-287-30	65219028730	10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10)	10 bottle	2023-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gadobutrol	Fresenius Kabi USA, LLC \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	4