Gadavist

Product NDC: 50419-325
11-digit product format: 504190325
Labeler code: 50419
Product ID: 50419-325_355ebf0b-3a4b-428a-90c2-38aa38308f03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gadobutrol
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA201277
Marketing category: NDA
Marketing start: 2011-03-14
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: 2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50419-325	50419-325-14	D	Discontinued by firm		2026-08-03
excluded package	package	50419-325	50419-325-15	D	Discontinued by firm		2026-08-03

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	RLD / RS	Approval date
N201277-001	GADAVIST	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-002	GADAVIST	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-003	GADAVIST	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-004	GADAVIST	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-005	GADAVIST	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-006	GADAVIST	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N201277-001	AP
N201277-002	AP
N201277-003	AP
N201277-004	AP
N201277-005	AP
N201277-006	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 7 · 246 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	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 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	N201277-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201277-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201277-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201277-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201277-004	AP	1	`2680178bc6a6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-001	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-002	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-003	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-004	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-005	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-006	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201277-001	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-002	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-003	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-004	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-005	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-006	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201277-001	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-002	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-003	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-004	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-005	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-006	I-801	2022-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201277-001	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-002	I-731	2019-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-002	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-003	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-004	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-005	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-006	I-801	2022-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201277-001	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-002	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-003	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-004	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-005	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-006	I-801	2022-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201277-001	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-002	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-003	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-004	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-005	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-006	I-801	2022-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-001	I-801	2022-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-002	I-801	2022-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-003	I-801	2022-07-12	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gadavist
Listing expiration: 2027-12-31

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
3c5101a0-0c7e-4078-8dc3-a57beb9a0e92	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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
50419-325-11	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-11	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-12	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-12	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-13	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-13	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-14	1030e365-0b0a-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-14	1030e365-0b0a-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-15	1030e365-0b0a-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-15	1030e365-0b0a-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-18	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-18	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-19	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-19	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-27	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-27	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-28	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-28	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-29	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-29	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-37	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-37	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-72	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-72	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-73	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-73	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-74	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-74	1030e365-5d93-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-75	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011
50419-325-75	1030e365-32fa-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50419-325-11	Gadavist	2 in 1 BOX	INJECTION	2	26
50419-325-11	Gadavist	10 in 1 CARTON	INJECTION	10	26
50419-325-12	Gadavist	10 in 1 CARTON	INJECTION	10	26
50419-325-12	Gadavist	2 in 1 BOX	INJECTION	2	26
50419-325-13	Gadavist	10 in 1 CARTON	INJECTION	10	26
50419-325-13	Gadavist	2 in 1 BOX	INJECTION	2	26
50419-325-27	Gadavist	5 in 1 BOX	INJECTION	5	26
50419-325-27	Gadavist	7.5 mL in 1 SYRINGE, GLASS	INJECTION	7.5	26
50419-325-28	Gadavist	5 in 1 BOX	INJECTION	5	26
50419-325-28	Gadavist	10 mL in 1 SYRINGE, GLASS	INJECTION	10	26
50419-325-29	Gadavist	5 in 1 BOX	INJECTION	5	26
50419-325-29	Gadavist	15 mL in 1 SYRINGE, GLASS	INJECTION	15	26
50419-325-37	Gadavist	3 in 1 CARTON	INJECTION	3	26
50419-325-37	Gadavist	15 in 1 BOX	INJECTION	15	26
50419-325-72	Gadavist	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10	26
50419-325-72	Gadavist	10 in 1 CARTON	INJECTION	10	26
50419-325-75	Gadavist	10 mL in 1 SYRINGE, GLASS	INJECTION	10	26
50419-325-75	Gadavist	5 in 1 BOX	INJECTION	5	26
50419-325-14	Gadavist	5 in 1 CARTON	INJECTION	5	23
50419-325-14	Gadavist	2 in 1 BOX	INJECTION	2	23
50419-325-15	Gadavist	65 mL in 1 BOTTLE, GLASS	INJECTION	65	23
50419-325-15	Gadavist	10 in 1 BOX	INJECTION	10	23
50419-325-18	Gadavist	5 in 1 CARTON	INJECTION	5	13
50419-325-18	Gadavist	2 in 1 BOX	INJECTION	2	13
50419-325-19	Gadavist	65 mL in 1 BOTTLE, GLASS	INJECTION	65	13
50419-325-19	Gadavist	10 in 1 BOX	INJECTION	10	13
50419-325-73	Gadavist	30 mL in 1 BOTTLE, GLASS	INJECTION	30	13
50419-325-74	Gadavist	65 mL in 1 BOTTLE, GLASS	INJECTION	65	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-325-11	ML - Milliliter	50419-325	ca4f5f25-f969-495c-8e99-f6cb688f32ef	1	2012-07-24
50419-325-12	ML - Milliliter	50419-325	b8287ea2-08fe-4e05-81b5-f31b9e227667	1	2012-07-24
50419-325-13	ML - Milliliter	50419-325	75fa5a9a-4166-4540-9e8e-623b41b15dd2	1	2012-07-24
50419-325-14	ML - Milliliter	50419-325	8457ebda-56c9-4f0e-a2ae-39f67669d415	1	2012-07-24
50419-325-15	ML - Milliliter	50419-325	7b0376e9-6179-4212-99c6-56ffc45e1f10	1	2012-07-24
50419-325-27	ML - Milliliter	50419-325	891bffd8-b289-463f-8407-8b546a0faaf2	1	2012-07-24
50419-325-28	ML - Milliliter	50419-325	56bd2db9-dd1d-41f9-b5af-5bed59ea9a3b	1	2012-07-24
50419-325-29	ML - Milliliter	50419-325	092078fd-f287-45f1-b849-1d75bd1d70b0	1	2012-07-24
50419-325-37	ML - Milliliter	50419-325	504636ea-956d-4820-a68d-6b7493412fc8	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GADOBUTROL	ACTIVE INGREDIENT	1BJ477IO2L	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
GADOLINIUM CATION (3+)	ACTIVE MOIETY	AZV954TZ9N	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
GADOBUTROL	ACTIVE INGREDIENT	1BJ477IO2L	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	6
GADOLINIUM CATION (3+)	ACTIVE MOIETY	AZV954TZ9N	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	6
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-325	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	24	Current NDC, Legacy NDC, 18 package rows	20250328_3c5101a0-0c7e-4078-8dc3-a57beb9a0e92.zip
50419-325	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	21	Current NDC, Legacy NDC, 4 package rows	20250328_bd28560f-de4d-4140-874e-31df823f4dbb.zip
50419-325	GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 6 package rows	20250328_b7afe34d-b70f-41a5-b89c-561bdf29f046.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
Gadavist	GADOBUTROL	Bayer HealthCare Pharmaceuticals Inc.	3c5101a0-0c7e-4078-8dc3-a57beb9a0e92	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201277 application number: NDA201277 ndc (product): 50419-325
Gadavist	GADOBUTROL	Bayer HealthCare Pharmaceuticals Inc.	b7afe34d-b70f-41a5-b89c-561bdf29f046	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201277 application number: NDA201277 ndc (product): 50419-325
Gadavist	GADOBUTROL	Bayer HealthCare Pharmaceuticals Inc.	bd28560f-de4d-4140-874e-31df823f4dbb	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201277 application number: NDA201277 ndc (product): 50419-325

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	Marketing end	Sample	Exclude flag	Status
50419-325-11	50419032511	2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE	2 carton	2011-03-15	0000-00-00	No	No	Current
50419-325-12	50419032512	2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE	2 carton	2011-03-15	0000-00-00	No	No	Current
50419-325-13	50419032513	2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE	2 carton	2011-03-15	0000-00-00	No	No	Current
50419-325-14	50419032514	2 CARTON in 1 BOX (50419-325-14) > 5 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS	2 carton	2011-03-15	2026-01-31	No	No	Current
50419-325-15	50419032515	10 BOTTLE, GLASS in 1 BOX (50419-325-15) > 65 mL in 1 BOTTLE, GLASS		2011-03-15	0000-00-00	No	No	Current
50419-325-18	50419032518	2 CARTON in 1 BOX (50419-325-18) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS	2 carton	2011-03-15	0000-00-00	No	No	Current
50419-325-19	50419032519	10 BOTTLE, GLASS in 1 BOX (50419-325-19) / 65 mL in 1 BOTTLE, GLASS		2011-03-15	0000-00-00	No	No	Current
50419-325-27	50419032527	5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS		2011-03-15	0000-00-00	No	No	Current
50419-325-28	50419032528	5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS		2011-03-15	0000-00-00	No	No	Current
50419-325-29	50419032529	5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS		2011-03-15	0000-00-00	No	No	Current
50419-325-37	50419032537	15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE	15 carton	2011-03-15	0000-00-00	No	No	Current
50419-325-72	50419032572	10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE		2011-03-15	0000-00-00	Yes	No	Current
50419-325-73	50419032573	30 mL in 1 BOTTLE, GLASS (50419-325-73)	30 ml	2021-02-11	0000-00-00	No	No	Current
50419-325-74	50419032574	65 mL in 1 BOTTLE, GLASS (50419-325-74)	65 ml	2021-02-11	0000-00-00	No	No	Current
50419-325-75	50419032575	5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS		2022-05-12	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gadavist	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Dynamit Nobel GmbH ES \| Sharp Corporation \| Quality Packaging Services International LLC \| Currenta GmbH & Co. OHG	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	26
Gadavist	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Dynamit Nobel GmbH ES \| Sharp Corporation \| Quality Packaging Services International LLC \| Currenta GmbH & Co. OHG	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	23
Gadavist	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	13