FDA.reportPublic FDA data

brivaracetam

Product NDC
70710-1585
11-digit product format
707101585
Labeler code
70710
Product ID
70710-1585_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
25 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

Additional Listing Data#

Finished product
Yes
Brand name base
brivaracetam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIVARACETAM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU863JGG2IA
Rxcui1739761, 1739768, 1739772, 1739776, 1739780

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1447c696-6954-40c0-b275-6f6c780ca8b7Product name120160323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1585-4brivaracetam100 in 1 CARTONTABLET, FILM COATED1004
70710-1585-6brivaracetam60 in 1 BOTTLETABLET, FILM COATED604
70710-1585-7brivaracetam1 in 1 BLISTER PACKTABLET, FILM COATED14
70710-1585-8brivaracetam180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739761brivaracetam 10 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739768brivaracetam 100 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739772brivaracetam 25 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739776brivaracetam 50 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739780brivaracetam 75 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739761brivaracetam 10 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739768brivaracetam 100 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739772brivaracetam 25 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739776brivaracetam 50 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739780brivaracetam 75 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1585-470710158504100 BLISTER PACK in 1 CARTON (70710-1585-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70710-1585-7) 100 blister pack2026-02-21NoNoCurrent
70710-1585-67071015850660 TABLET, FILM COATED in 1 BOTTLE (70710-1585-6) 2026-02-21NoNoCurrent
70710-1585-7707101585071 in 1 BLISTER PACKHistorical
70710-1585-870710158508180 TABLET, FILM COATED in 1 BOTTLE (70710-1585-8) 2026-02-21NoNoCurrent