Home NDC 84386-068 Brivaracetam
Product NDC 84386-068
11-digit product format 843860068
Labeler code 84386
Product ID 84386-068_59817617-956e-4685-81d4-7abe42f4de86
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 2026-07-13
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 43 .
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 · 58 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 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 6a51e52b5d6a…
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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1739761 Internal RxNorm lookup 1739772 Internal RxNorm lookup 1739780 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84386-068-60 84386006860 60 TABLET, FILM COATED in 1 BOTTLE (84386-068-60) 2026-07-13 No No Current