Briviact

Product NDC: 50474-970
Requested package NDC: 50474-970-75
11-digit product format: 504740970
Labeler code: 50474
Product ID: 50474-970_51b3e2db-678a-dd8b-e063-6394a90aed7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brivaracetam
Dosage form: INJECTION, SUSPENSION
Route: INTRAVENOUS
Labeler: UCB, Inc.
Application: NDA205837
Marketing category: NDA
Marketing start: 2016-05-12
Substance: BRIVARACETAM
Active strength: 50 mg/5mL
Pharmacologic classes: Epoxide Hydrolase Inhibitors [MoA]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205837-001	BRIVIACT	BRIVARACETAM	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2016-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N205837-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25
N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25

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 · 41 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	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205837-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6784197	2021-02-21	U-2130	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6784197	2021-02-21	U-1815	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6911461	2021-02-21	U-1815	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6911461	2021-02-21	U-2130	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	8492416	2021-02-21	U-2130		2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	8492416	2021-02-21	U-1815		2016-02-25	`74a2ff9319b5…`

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	N205837-001	NPP	2024-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	NPP	2024-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	NPP	2024-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	NPP	2024-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205837-001	NPP	2024-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	NPP	2024-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	NPP	2024-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	NPP	2024-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205837-001	NPP	2024-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	NPP	2024-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205837-001	NPP	2024-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205837-001	NPP	2024-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205837-001	NCE	2021-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205837-001	NPP	2024-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205837-001	NCE	2021-05-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205837-001	NPP	2024-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205837-001	NCE	2021-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205837-001	NCE	2021-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205837-001	NCE	2021-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205837-001	NCE	2021-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205837-001	NCE	2021-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205837-001	NCE	2021-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205837-001	NCE	2021-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205837-001	NPP	2024-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205837-001	NPP	2024-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205837-001	NPP	2024-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205837-001	NPP	2024-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205837-001	NPP	2024-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205837-001	NPP	2024-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205837-001	NPP	2024-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205837-001	NPP	2024-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205837-001	NPP	2024-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205837-001	NPP	2024-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205837-001	NPP	2024-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205837-001	NPP	2024-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205837-001	NPP	2024-08-27	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRIVARACETAM	50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U863JGG2IA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1739749	Internal RxNorm lookup
1739754	Internal RxNorm lookup
1739761	Internal RxNorm lookup
1739766	Internal RxNorm lookup
1739768	Internal RxNorm lookup
1739770	Internal RxNorm lookup
1739772	Internal RxNorm lookup
1739774	Internal RxNorm lookup
1739776	Internal RxNorm lookup
1739778	Internal RxNorm lookup
1739780	Internal RxNorm lookup
1739782	Internal RxNorm lookup
1739785	Internal RxNorm lookup
1739788	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3cf2f439-0e97-443e-8e33-25ecef616f6c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
1447c696-6954-40c0-b275-6f6c780ca8b7	Product name	1	20160323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50474-970-63	Briviact	5 mL in 1 VIAL, GLASS	INJECTION, SUSPENSION	5		26
50474-970-75	Briviact	10 in 1 CARTON	INJECTION, SUSPENSION	10		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50474-970-63	ML - Milliliter	50474-970	992faa98-438d-40b8-879d-309c5c8bb72e	1	2016-06-14
50474-970-75	ML - Milliliter	50474-970	cbb39319-81fc-4e6f-bca1-626d52400909	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50474-970	BRIVIACT (BRIVARACETAM) TABLET, FILM COATED BRIVIACT (BRIVARACETAM) SOLUTION BRIVIACT (BRIVARACETAM) INJECTION, SUSPENSION [UCB, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20230526_3cf2f439-0e97-443e-8e33-25ecef616f6c.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
Briviact	BRIVARACETAM	UCB, Inc.	3cf2f439-0e97-443e-8e33-25ecef616f6c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205837 application number: NDA205837 ndc (package): 50474-970-75 ndc (product): 50474-970 ndc11 (package): 50474097075

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U863JGG2IA	BRIVARACETAM	357336-20-0	BRIVARACETAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1739785	brivaracetam 10 MG in 1 mL Oral Solution	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739761	brivaracetam 10 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739768	brivaracetam 100 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739772	brivaracetam 25 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739749	brivaracetam 50 MG in 5 ML Injection	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739776	brivaracetam 50 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739780	brivaracetam 75 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739788	BRIVIACT 10 MG in 1 mL Oral Solution	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739766	Briviact 10 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739770	Briviact 100 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739774	Briviact 25 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739754	Briviact 50 MG in 5 ML Injection	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739778	Briviact 50 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739782	Briviact 75 MG Oral Tablet	PSN	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739754	5 ML brivaracetam 10 MG/ML Injection [Briviact]	SBD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739766	brivaracetam 10 MG Oral Tablet [Briviact]	SBD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739788	brivaracetam 10 MG/ML Oral Solution [Briviact]	SBD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739770	brivaracetam 100 MG Oral Tablet [Briviact]	SBD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739774	brivaracetam 25 MG Oral Tablet [Briviact]	SBD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739778	brivaracetam 50 MG Oral Tablet [Briviact]	SBD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739782	brivaracetam 75 MG Oral Tablet [Briviact]	SBD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739749	5 ML brivaracetam 10 MG/ML Injection	SCD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739761	brivaracetam 10 MG Oral Tablet	SCD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739785	brivaracetam 10 MG/ML Oral Solution	SCD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739768	brivaracetam 100 MG Oral Tablet	SCD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739772	brivaracetam 25 MG Oral Tablet	SCD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739776	brivaracetam 50 MG Oral Tablet	SCD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739780	brivaracetam 75 MG Oral Tablet	SCD	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739754	5 ML Briviact 10 MG/ML Injection	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739785	brivaracetam 10 MG per 1 ML Oral Solution	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739749	brivaracetam 50 MG per 5 ML Injection	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739766	Briviact 10 MG Oral Tablet	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739788	Briviact 10 MG per 1 ML Oral Solution	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739770	Briviact 100 MG Oral Tablet	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739774	Briviact 25 MG Oral Tablet	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739778	Briviact 50 MG Oral Tablet	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739754	Briviact 50 MG per 5 ML Injection	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26
1739782	Briviact 75 MG Oral Tablet	SY	3cf2f439-0e97-443e-8e33-25ecef616f6c	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50474-970-75	50474097075	10 VIAL, GLASS in 1 CARTON (50474-970-75) / 5 mL in 1 VIAL, GLASS (50474-970-63)	2016-05-12	0000-00-00	No	No	Current