Home NDC 50474-370 Briviact
Product NDC 50474-370
11-digit product format 504740370
Labeler code 50474
Product ID 50474-370_51b3e2db-678a-dd8b-e063-6394a90aed7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brivaracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler UCB, Inc.
Application NDA205836
Marketing category NDA
Marketing start 2016-05-12
Substance BRIVARACETAM
Active strength 10 mg/1
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205836-001 BRIVIACT BRIVARACETAM 10MG TABLET / ORAL AB RLD 2016-05-12 N205836-002 BRIVIACT BRIVARACETAM 25MG TABLET / ORAL AB RLD 2016-05-12 N205836-003 BRIVIACT BRIVARACETAM 50MG TABLET / ORAL AB RLD 2016-05-12 N205836-004 BRIVIACT BRIVARACETAM 75MG TABLET / ORAL AB RLD 2016-05-12 N205836-005 BRIVIACT BRIVARACETAM 100MG TABLET / ORAL AB RLD, RS 2016-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205836-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 N205836-001 10729653 2030-04-09 Drug product 2020-08-18 N205836-002 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 N205836-002 10729653 2030-04-09 Drug product 2020-08-18 N205836-003 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 N205836-003 10729653 2030-04-09 Drug product 2020-08-18 N205836-004 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 N205836-004 10729653 2030-04-09 Drug product 2020-08-18 N205836-005 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 N205836-005 10729653 2030-04-09 Drug product 2020-08-18
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 6 · 205 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 N205836-001 BRIVIACT 10MG TABLET / ORAL AB RLD 2016-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-002 BRIVIACT 25MG TABLET / ORAL AB RLD 2016-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-003 BRIVIACT 50MG TABLET / ORAL AB RLD 2016-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-004 BRIVIACT 75MG TABLET / ORAL AB RLD 2016-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-005 BRIVIACT 100MG TABLET / ORAL AB RLD, RS 2016-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-001 BRIVIACT 10MG TABLET / ORAL AB RLD 2016-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-002 BRIVIACT 25MG TABLET / ORAL AB RLD 2016-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-003 BRIVIACT 50MG TABLET / ORAL AB RLD 2016-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-004 BRIVIACT 75MG TABLET / ORAL AB RLD 2016-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-005 BRIVIACT 100MG TABLET / ORAL AB RLD, RS 2016-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205836-001 BRIVIACT 10MG TABLET / ORAL RLD 2016-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-002 BRIVIACT 25MG TABLET / ORAL RLD 2016-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-003 BRIVIACT 50MG TABLET / ORAL RLD 2016-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-004 BRIVIACT 75MG TABLET / ORAL RLD 2016-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-005 BRIVIACT 100MG TABLET / ORAL RLD, RS 2016-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-001 BRIVIACT 10MG TABLET / ORAL RLD 2016-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-002 BRIVIACT 25MG TABLET / ORAL RLD 2016-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-003 BRIVIACT 50MG TABLET / ORAL RLD 2016-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-004 BRIVIACT 75MG TABLET / ORAL RLD 2016-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-005 BRIVIACT 100MG TABLET / ORAL RLD, RS 2016-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205836-001 BRIVIACT 10MG TABLET / ORAL RLD 2016-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205836-002 BRIVIACT 25MG TABLET / ORAL RLD 2016-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205836-003 BRIVIACT 50MG TABLET / ORAL RLD 2016-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205836-004 BRIVIACT 75MG TABLET / ORAL RLD 2016-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205836-005 BRIVIACT 100MG TABLET / ORAL RLD, RS 2016-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205836-001 BRIVIACT 10MG TABLET / ORAL RLD 2016-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205836-002 BRIVIACT 25MG TABLET / ORAL RLD 2016-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205836-003 BRIVIACT 50MG TABLET / ORAL RLD 2016-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205836-004 BRIVIACT 75MG TABLET / ORAL RLD 2016-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205836-005 BRIVIACT 100MG TABLET / ORAL RLD, RS 2016-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205836-001 BRIVIACT 10MG TABLET / ORAL RLD 2016-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205836-002 BRIVIACT 25MG TABLET / ORAL RLD 2016-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205836-003 BRIVIACT 50MG TABLET / ORAL RLD 2016-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205836-004 BRIVIACT 75MG TABLET / ORAL RLD 2016-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205836-005 BRIVIACT 100MG TABLET / ORAL RLD, RS 2016-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205836-001 BRIVIACT 10MG TABLET / ORAL RLD 2016-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205836-002 BRIVIACT 25MG TABLET / ORAL RLD 2016-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205836-003 BRIVIACT 50MG TABLET / ORAL RLD 2016-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205836-004 BRIVIACT 75MG TABLET / ORAL RLD 2016-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205836-005 BRIVIACT 100MG TABLET / ORAL RLD, RS 2016-05-12 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 12 · 480 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 N205836-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-001 10729653 2030-04-09 Drug product 2020-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-002 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-002 10729653 2030-04-09 Drug product 2020-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-003 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-003 10729653 2030-04-09 Drug product 2020-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-004 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-004 10729653 2030-04-09 Drug product 2020-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-005 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205836-005 10729653 2030-04-09 Drug product 2020-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-001 10729653 2030-04-09 Drug product 2020-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-002 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-002 10729653 2030-04-09 Drug product 2020-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-003 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-003 10729653 2030-04-09 Drug product 2020-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-004 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-004 10729653 2030-04-09 Drug product 2020-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-005 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205836-005 10729653 2030-04-09 Drug product 2020-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205836-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-001 10729653 2030-04-09 Drug product 2020-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-002 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-002 10729653 2030-04-09 Drug product 2020-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-003 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-003 10729653 2030-04-09 Drug product 2020-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-004 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-004 10729653 2030-04-09 Drug product 2020-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-005 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205836-005 10729653 2030-04-09 Drug product 2020-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-001 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-001 10729653 2030-04-09 Drug product 2020-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-002 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-002 10729653 2030-04-09 Drug product 2020-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-003 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-003 10729653 2030-04-09 Drug product 2020-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-004 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-004 10729653 2030-04-09 Drug product 2020-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-005 6911461 2026-02-21 U-2295 Drug substance, Drug product 2016-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205836-005 10729653 2030-04-09 Drug product 2020-08-18 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 195 observed states.
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/1
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 50474-370-66 Briviact 60 in 1 BOTTLE TABLET, FILM COATED 60 26 50474-370-66 Briviact 1 in 1 CARTON TABLET, FILM COATED 1 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-370 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 50474-370-66 50474037066 1 BOTTLE in 1 CARTON (50474-370-66) / 60 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2016-05-12 0000-00-00 No No Current