Home NDC 84386-070 Brivaracetam
Product NDC 84386-070
11-digit product format 843860070
Labeler code 84386
Product ID 84386-070_da0a62cb-4446-46f0-9fa6-d94dab33a2b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brivaracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA214848
Marketing category ANDA
Marketing start 2026-02-25
Substance BRIVARACETAM
Active strength 50 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 44 .
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 A214848-001 BRIVARACETAM BRIVARACETAM 50MG TABLET / ORAL AB 2023-01-06 A214848-002 BRIVARACETAM BRIVARACETAM 100MG TABLET / ORAL AB 2023-01-06 A214848-003 BRIVARACETAM BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-13 A214848-004 BRIVARACETAM BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-13 A214848-005 BRIVARACETAM BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 · 63 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 2026-10-15 13:18:30 2026-09 A214848-001 BRIVARACETAM 50MG TABLET / ORAL AB 2023-01-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214848-002 BRIVARACETAM 100MG TABLET / ORAL AB 2023-01-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214848-003 BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214848-004 BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214848-005 BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214848-001 BRIVARACETAM 50MG TABLET / ORAL AB 2023-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214848-002 BRIVARACETAM 100MG TABLET / ORAL AB 2023-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214848-003 BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214848-004 BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214848-005 BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214848-001 BRIVARACETAM 50MG TABLET / ORAL AB 2023-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214848-002 BRIVARACETAM 100MG TABLET / ORAL AB 2023-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214848-003 BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214848-004 BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214848-005 BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214848-001 BRIVARACETAM 50MG TABLET / ORAL AB 2023-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214848-002 BRIVARACETAM 100MG TABLET / ORAL AB 2023-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 1e350fbaab3a…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Brivaracetam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIVARACETAM 50 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84386-070-60 Brivaracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84386-070-60 84386007060 60 TABLET, FILM COATED in 1 BOTTLE (84386-070-60) 2026-02-25 No No Current