FDA.reportPublic FDA data

BRIVARACETAM

Product NDC
76282-824
11-digit product format
762820824
Labeler code
76282
Product ID
76282-824_a72c2804-469d-4405-b2b2-1d0ea7c9a7e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BRIVARACETAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc
Application
ANDA219952
Marketing category
ANDA
Marketing start
2026-07-28
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219952-001BRIVARACETAMBRIVARACETAM10MGTABLET / ORALAB2026-07-01
A219952-002BRIVARACETAMBRIVARACETAM25MGTABLET / ORALAB2026-07-01
A219952-003BRIVARACETAMBRIVARACETAM50MGTABLET / ORALAB2026-07-01
A219952-004BRIVARACETAMBRIVARACETAM75MGTABLET / ORALAB2026-07-01
A219952-005BRIVARACETAMBRIVARACETAM100MGTABLET / ORALAB2026-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A219952-001AB
A219952-002AB
A219952-003AB
A219952-004AB
A219952-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219952-001BRIVARACETAM10MGTABLET / ORALAB2026-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A219952-002BRIVARACETAM25MGTABLET / ORALAB2026-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A219952-003BRIVARACETAM50MGTABLET / ORALAB2026-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A219952-004BRIVARACETAM75MGTABLET / ORALAB2026-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A219952-005BRIVARACETAM100MGTABLET / ORALAB2026-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A219952-001BRIVARACETAM10MGTABLET / ORALAB2026-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-002BRIVARACETAM25MGTABLET / ORALAB2026-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-003BRIVARACETAM50MGTABLET / ORALAB2026-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-004BRIVARACETAM75MGTABLET / ORALAB2026-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-005BRIVARACETAM100MGTABLET / ORALAB2026-07-01caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-001BRIVARACETAM10MGTABLET / ORALAB2026-07-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-002BRIVARACETAM25MGTABLET / ORALAB2026-07-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-003BRIVARACETAM50MGTABLET / ORALAB2026-07-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-004BRIVARACETAM75MGTABLET / ORALAB2026-07-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-005BRIVARACETAM100MGTABLET / ORALAB2026-07-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219952-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219952-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A219952-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A219952-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A219952-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A219952-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219952-005AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219952-005AB1a50c72e98297…

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
IngredientStrength
BRIVARACETAM50 mg/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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRIVARACETAMBRIVARACETAMExelan Pharmaceuticals, Incbf372f42-cfc9-4fcf-8226-3936ba8833d72026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219952
application number: ANDA219952
ndc (product): 76282-824
brivaracetamBRIVARACETAMScieGen Pharmaceuticals, Inc.bdbb6756-654c-46f1-a85c-7d5d1a89685a2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219952
application number: ANDA219952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76282-824-607628208246060 TABLET, FILM COATED in 1 BOTTLE (76282-824-60) 2026-07-28NoNoCurrent