Home NDC 84386-070 Brivaracetam
Product NDC 84386-070
11-digit product format 843860070
Labeler code 84386
Product ID 84386-070_921bd2d8-0135-469e-8c63-555bc1190234
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 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
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 48 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 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…2024-02-18 07:12 UTC 2024-02 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214848-001 BRIVARACETAM 50MG TABLET / ORAL 2023-01-06 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214848-002 BRIVARACETAM 100MG TABLET / ORAL 2023-01-06 a67488948f0b…
Observed Orange Book normalized TE history# 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
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1739768 Internal RxNorm lookup 1739776 Internal RxNorm lookup
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 84386-070-60 Brivaracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 3
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.
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