gadobutrol

Product NDC: 70436-213
Requested package NDC: 70436-213-82
11-digit product format: 704360213
Labeler code: 70436
Product ID: 70436-213_3304f07e-e137-e806-e063-6394a90a8a4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gadobutrol
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Slate Run Pharmaceuticals, LLC
Application: ANDA217480
Marketing category: ANDA
Marketing start: 2025-04-16
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
A217480-001	GADOBUTROL	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15
A217480-002	GADOBUTROL	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15
A217480-003	GADOBUTROL	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16
A217480-004	GADOBUTROL	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16
A217480-005	GADOBUTROL	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16
A217480-006	GADOBUTROL	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A217480-001	AP
A217480-002	AP
A217480-003	AP
A217480-004	AP
A217480-005	AP
A217480-006	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 2 · 62 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	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-004	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-005	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-006	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-004	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-005	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-006	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-004	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-005	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-006	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2025-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217480-001	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217480-002	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-03-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A217480-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217480-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217480-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217480-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217480-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217480-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217480-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217480-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217480-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217480-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217480-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217480-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217480-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217480-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217480-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217480-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217480-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217480-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217480-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217480-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217480-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217480-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217480-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217480-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217480-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217480-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217480-002	AP	1	`8072bd15b7f6…`

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
832e0ae1-4fe1-4dff-9978-c9200bcebb55	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
70436-213-33	gadobutrol	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		4
70436-213-82	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
70436-213	GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC]	4	Current NDC, 2 package rows	20250419_832e0ae1-4fe1-4dff-9978-c9200bcebb55.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gadobutrol	GADOBUTROL	Slate Run Pharmaceuticals, LLC	52fbda34-9974-4f9f-9749-6b17d0495b62	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217480 application number: ANDA217480
gadobutrol	GADOBUTROL	Slate Run Pharmaceuticals, LLC	832e0ae1-4fe1-4dff-9978-c9200bcebb55	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217480 application number: ANDA217480 ndc (package): 70436-213-82 ndc (product): 70436-213 ndc11 (package): 70436021382
gadobutrol	GADOBUTROL	Slate Run Pharmaceuticals, LLC	4af6ee2b-d039-497f-a8f0-bdf948e5f54e	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217480 application number: ANDA217480

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	Marketing start	Sample	Exclude flag	Status
70436-213-82	70436021382	10 VIAL, SINGLE-DOSE in 1 CARTON (70436-213-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-213-33)	2025-04-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
gadobutrol	Slate Run Pharmaceuticals, LLC \| Hainan Poly Pharm. Co., Ltd.	2025-04-17	HUMAN PRESCRIPTION DRUG LABEL	4