Home NDC 70710-1586 brivaracetam
Product NDC 70710-1586
11-digit product format 707101586
Labeler code 70710
Product ID 70710-1586_dd7c5f3e-5cd5-4219-bf1a-7fe15b291998
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brivaracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA214501
Marketing category ANDA
Marketing start 2026-02-21
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214501-001 BRIVARACETAM BRIVARACETAM 10MG TABLET / ORAL AB 2022-10-03 A214501-002 BRIVARACETAM BRIVARACETAM 25MG TABLET / ORAL AB 2022-10-03 A214501-003 BRIVARACETAM BRIVARACETAM 50MG TABLET / ORAL AB 2022-10-03 A214501-004 BRIVARACETAM BRIVARACETAM 75MG TABLET / ORAL AB 2022-10-03 A214501-005 BRIVARACETAM BRIVARACETAM 100MG TABLET / ORAL AB 2022-10-03
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 4 · 130 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 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214501-001 BRIVARACETAM 10MG TABLET / ORAL 2022-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214501-002 BRIVARACETAM 25MG TABLET / ORAL 2022-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214501-003 BRIVARACETAM 50MG TABLET / ORAL 2022-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214501-004 BRIVARACETAM 75MG TABLET / ORAL 2022-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214501-005 BRIVARACETAM 100MG TABLET / ORAL 2022-10-03 5bbf6a4d5a75…
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1739761 Internal RxNorm lookup 1739768 Internal RxNorm lookup 1739772 Internal RxNorm lookup 1739776 Internal RxNorm lookup 1739780 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 70710-1586-4 brivaracetam 100 in 1 CARTON TABLET, FILM COATED 100 4 70710-1586-6 brivaracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 4 70710-1586-7 brivaracetam 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4 70710-1586-8 brivaracetam 180 in 1 BOTTLE TABLET, FILM COATED 180 4
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 Units Marketing start Sample Exclude flag Status 70710-1586-4 70710158604 100 BLISTER PACK in 1 CARTON (70710-1586-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70710-1586-7) 100 blister pack 2026-02-21 No No Current 70710-1586-6 70710158606 60 TABLET, FILM COATED in 1 BOTTLE (70710-1586-6) 2026-02-21 No No Current 70710-1586-7 70710158607 1 in 1 BLISTER PACK Historical 70710-1586-8 70710158608 180 TABLET, FILM COATED in 1 BOTTLE (70710-1586-8) 2026-02-21 No No Current