brivaracetam

Product NDC
70771-1758
11-digit product format
707711758
Labeler code
70771
Product ID
70771-1758_43d4b6c1-4756-4199-90f9-d91d9c81c861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brivaracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA214501
Marketing category
ANDA
Marketing start
2026-02-21
Substance
BRIVARACETAM
Active strength
100 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
BRIVARACETAM100 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
70771-1758-4brivaracetam100 in 1 CARTONTABLET, FILM COATED1004
70771-1758-6brivaracetam60 in 1 BOTTLETABLET, FILM COATED604
70771-1758-7brivaracetam1 in 1 BLISTER PACKTABLET, FILM COATED14
70771-1758-8brivaracetam180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739761brivaracetam 10 MG Oral TabletPSN67c4db20-ba4d-4640-9e9c-6949b85429e34
1739768brivaracetam 100 MG Oral TabletPSN67c4db20-ba4d-4640-9e9c-6949b85429e34
1739772brivaracetam 25 MG Oral TabletPSN67c4db20-ba4d-4640-9e9c-6949b85429e34
1739776brivaracetam 50 MG Oral TabletPSN67c4db20-ba4d-4640-9e9c-6949b85429e34
1739780brivaracetam 75 MG Oral TabletPSN67c4db20-ba4d-4640-9e9c-6949b85429e34
1739761brivaracetam 10 MG Oral TabletSCD67c4db20-ba4d-4640-9e9c-6949b85429e34
1739768brivaracetam 100 MG Oral TabletSCD67c4db20-ba4d-4640-9e9c-6949b85429e34
1739772brivaracetam 25 MG Oral TabletSCD67c4db20-ba4d-4640-9e9c-6949b85429e34
1739776brivaracetam 50 MG Oral TabletSCD67c4db20-ba4d-4640-9e9c-6949b85429e34
1739780brivaracetam 75 MG Oral TabletSCD67c4db20-ba4d-4640-9e9c-6949b85429e34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1758-470771175804100 BLISTER PACK in 1 CARTON (70771-1758-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70771-1758-7) 100 blister pack2026-02-21NoNoHistorical
70771-1758-67077117580660 TABLET, FILM COATED in 1 BOTTLE (70771-1758-6) 2026-02-21NoNoHistorical
70771-1758-7707711758071 in 1 BLISTER PACKHistorical
70771-1758-870771175808180 TABLET, FILM COATED in 1 BOTTLE (70771-1758-8) 2026-02-21NoNoHistorical