Home NDC 50474-870-15 Briviact
Product NDC 50474-870
Requested package NDC 50474-870-15
11-digit product format 504740870
Labeler code 50474
Product ID 50474-870_51b3e2db-678a-dd8b-e063-6394a90aed7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brivaracetam
Dosage form SOLUTION
Route ORAL
Labeler UCB, Inc.
Application NDA205838
Marketing category NDA
Marketing start 2016-05-12
Substance BRIVARACETAM
Active strength 10 mg/mL
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 N205838-001 BRIVIACT BRIVARACETAM 10MG/ML SOLUTION / ORAL AA 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 N205838-001 AA
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205838-001 6911461 2026-02-21 U-2295 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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL RLD, RS 2016-05-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205838-001 BRIVIACT 10MG/ML SOLUTION / ORAL 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 N205838-001 AA 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 59 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 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205838-001 6911461 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205838-001 8492416 2021-02-21 U-2295 2016-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205838-001 8492416 2021-02-21 U-2295 2016-02-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205838-001 8492416 2021-02-21 U-2295 2016-02-25 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N205838-001 8492416 2021-02-21 U-2295 2016-02-25 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N205838-001 8492416 2021-02-21 U-2295 2016-02-25 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N205838-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N205838-001 6911461 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N205838-001 8492416 2021-02-21 U-2295 2016-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N205838-001 6911461 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N205838-001 8492416 2021-02-21 U-2295 2016-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205838-001 6784197 2021-02-21 U-2295 Drug substance, Drug product 2016-02-25 b00525d2431f…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Briviact
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIVARACETAM 10 mg/mL
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.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50474-870-15 Briviact 1 in 1 CARTON SOLUTION 1 26 50474-870-15 Briviact 300 mL in 1 BOTTLE SOLUTION 300 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-870 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50474-870-15 50474087015 1 BOTTLE in 1 CARTON (50474-870-15) / 300 mL in 1 BOTTLE 1 bottle 2016-05-12 0000-00-00 No No Current