Home NDC 60505-4723 Brivaracetam
Product NDC 60505-4723
11-digit product format 605054723
Labeler code 60505
Product ID 60505-4723_a2119162-90a5-0d0c-9d3b-6364bf087960
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brivaracetam
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA214875
Marketing category ANDA
Marketing start 2026-02-24
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 A214875-001 BRIVARACETAM BRIVARACETAM 10MG TABLET / ORAL AB 2026-02-23 A214875-002 BRIVARACETAM BRIVARACETAM 25MG TABLET / ORAL AB 2026-02-23 A214875-003 BRIVARACETAM BRIVARACETAM 50MG TABLET / ORAL AB 2026-02-23 A214875-004 BRIVARACETAM BRIVARACETAM 75MG TABLET / ORAL AB 2026-02-23 A214875-005 BRIVARACETAM BRIVARACETAM 100MG TABLET / ORAL AB 2026-02-23
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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-001 BRIVARACETAM 10MG TABLET / ORAL AB 2026-02-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-002 BRIVARACETAM 25MG TABLET / ORAL AB 2026-02-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-003 BRIVARACETAM 50MG TABLET / ORAL AB 2026-02-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-004 BRIVARACETAM 75MG TABLET / ORAL AB 2026-02-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-005 BRIVARACETAM 100MG TABLET / ORAL AB 2026-02-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214875-005 AB 1 a50c72e98297…
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 · 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 60505-4723-6 Brivaracetam 60 in 1 BOTTLE TABLET 60 2
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 Sample Exclude flag Status 60505-4723-6 60505472306 60 TABLET in 1 BOTTLE (60505-4723-6) 60 tablet 2026-02-24 No No Current