Home NDC 72205-270 brivaracetam
Product NDC 72205-270
11-digit product format 722050270
Labeler code 72205
Product ID 72205-270_11ca0e1d-1c0d-4357-9ebd-ee1e87185dde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brivaracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA214921
Marketing category ANDA
Marketing start 2025-11-13
Substance BRIVARACETAM
Active strength 75 mg/1
Pharmacologic classes Epoxide Hydrolase Inhibitors [MoA]
DEA schedule CV
NDC exclude flag No
Listing certified through 2026-12-31
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 A214921-001 BRIVARACETAM BRIVARACETAM 10MG TABLET / ORAL AB 2025-11-13 A214921-002 BRIVARACETAM BRIVARACETAM 25MG TABLET / ORAL AB 2025-11-13 A214921-003 BRIVARACETAM BRIVARACETAM 50MG TABLET / ORAL AB 2025-11-13 A214921-004 BRIVARACETAM BRIVARACETAM 75MG TABLET / ORAL AB 2025-11-13 A214921-005 BRIVARACETAM BRIVARACETAM 100MG TABLET / ORAL AB 2025-11-13
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.
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 A214921-001 BRIVARACETAM 10MG TABLET / ORAL AB 2025-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214921-002 BRIVARACETAM 25MG TABLET / ORAL AB 2025-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214921-003 BRIVARACETAM 50MG TABLET / ORAL AB 2025-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214921-004 BRIVARACETAM 75MG TABLET / ORAL AB 2025-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214921-005 BRIVARACETAM 100MG TABLET / ORAL AB 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214921-001 BRIVARACETAM 10MG TABLET / ORAL AB 2025-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214921-002 BRIVARACETAM 25MG TABLET / ORAL AB 2025-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214921-003 BRIVARACETAM 50MG TABLET / ORAL AB 2025-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214921-004 BRIVARACETAM 75MG TABLET / ORAL AB 2025-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214921-005 BRIVARACETAM 100MG TABLET / ORAL AB 2025-11-13 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214921-001 BRIVARACETAM 10MG TABLET / ORAL AB 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214921-002 BRIVARACETAM 25MG TABLET / ORAL AB 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214921-003 BRIVARACETAM 50MG TABLET / ORAL AB 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214921-004 BRIVARACETAM 75MG TABLET / ORAL AB 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214921-005 BRIVARACETAM 100MG TABLET / ORAL AB 2025-11-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base brivaracetam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIVARACETAM 75 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 72205-270-60 brivaracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 1
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 72205-270-60 72205027060 60 TABLET, FILM COATED in 1 BOTTLE (72205-270-60) 2026-02-01 No No Current