Home NDC 50228-558 brivaracetam
Product NDC 50228-558
11-digit product format 502280558
Labeler code 50228
Product ID 50228-558_193abd80-412f-44b3-8dc7-1c47011c58b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brivaracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA219952
Marketing category ANDA
Marketing start 2026-03-27
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 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 A219952-001 BRIVARACETAM BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-01 A219952-002 BRIVARACETAM BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-01 A219952-003 BRIVARACETAM BRIVARACETAM 50MG TABLET / ORAL AB 2026-07-01 A219952-004 BRIVARACETAM BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-01 A219952-005 BRIVARACETAM BRIVARACETAM 100MG TABLET / ORAL AB 2026-07-01
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 2026-09-14 22:38:34 2026-08 A219952-001 BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219952-002 BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219952-003 BRIVARACETAM 50MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219952-004 BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219952-005 BRIVARACETAM 100MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219952-001 BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219952-002 BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219952-003 BRIVARACETAM 50MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219952-004 BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219952-005 BRIVARACETAM 100MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219952-001 BRIVARACETAM 10MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219952-002 BRIVARACETAM 25MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219952-003 BRIVARACETAM 50MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219952-004 BRIVARACETAM 75MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219952-005 BRIVARACETAM 100MG TABLET / ORAL AB 2026-07-01 a50c72e98297…
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 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.
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 50228-558-10 50228055810 1000 TABLET, FILM COATED in 1 BOTTLE (50228-558-10) 2026-03-27 No No Current 50228-558-30 50228055830 30 TABLET, FILM COATED in 1 BOTTLE (50228-558-30) 2026-03-27 No No Current 50228-558-60 50228055860 60 TABLET, FILM COATED in 1 BOTTLE (50228-558-60) 2026-03-27 No No Current