National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:04:19

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-325-13	ML - Milliliter	50419-325	75fa5a9a-4166-4540-9e8e-623b41b15dd2	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50419-325	50419-325-13

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 258 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	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N201277-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-006	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201277-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-006	AP	1	`caaa826d4ba7…`
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…`

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…`

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
Gadavist	GADOBUTROL	Bayer HealthCare Pharmaceuticals Inc.	3c5101a0-0c7e-4078-8dc3-a57beb9a0e92	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 50419-325-13 ndc11 (package): 50419032513

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.