brivaracetam

Product NDC
72205-268
11-digit product format
722050268
Labeler code
72205
Product ID
72205-268_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
25 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

Additional Listing Data#

Finished product
Yes
Brand name base
brivaracetam
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
1447c696-6954-40c0-b275-6f6c780ca8b7Product name120160323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-268-06brivaracetam100 in 1 CARTONTABLET, FILM COATED1001
72205-268-06brivaracetam1 in 1 BLISTER PACKTABLET, FILM COATED11
72205-268-60brivaracetam60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-268-06EA - Each72205-268f49dd749-7be8-413a-80b2-4eb9c149ca1812026-03-17
72205-268-60EA - Each72205-2686f566d9d-2d7a-4cfa-a277-ff79ebcbdd0812026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739761brivaracetam 10 MG Oral TabletPSN11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739768brivaracetam 100 MG Oral TabletPSN11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739772brivaracetam 25 MG Oral TabletPSN11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739776brivaracetam 50 MG Oral TabletPSN11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739780brivaracetam 75 MG Oral TabletPSN11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739761brivaracetam 10 MG Oral TabletSCD11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739768brivaracetam 100 MG Oral TabletSCD11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739772brivaracetam 25 MG Oral TabletSCD11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739776brivaracetam 50 MG Oral TabletSCD11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1
1739780brivaracetam 75 MG Oral TabletSCD11ca0e1d-1c0d-4357-9ebd-ee1e87185dde1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-268-0672205026806100 BLISTER PACK in 1 CARTON (72205-268-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2026-02-01NoNoCurrent
72205-268-607220502686060 TABLET, FILM COATED in 1 BOTTLE (72205-268-60) 2026-02-01NoNoCurrent