brivaracetam

Product NDC
72673-031
11-digit product format
726730031
Labeler code
72673
Product ID
72673-031_4a887cf9-ddd0-b8ce-e063-6294a90afc47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brivaracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Zhejiang Poly Pharm. Co., Ltd.
Application
ANDA218494
Marketing category
ANDA
Marketing start
2026-02-21
Substance
BRIVARACETAM
Active strength
10 mg/mL
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
BRIVARACETAM10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU863JGG2IA
Rxcui1739785

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
72673-031-10brivaracetam300 mL in 1 BOTTLESOLUTION3001
72673-031-10brivaracetam1 in 1 CARTONSOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739785brivaracetam 10 MG in 1 mL Oral SolutionPSNaef3ee92-e2a6-4135-94b2-b893f893d5f21
1739785brivaracetam 10 MG/ML Oral SolutionSCDaef3ee92-e2a6-4135-94b2-b893f893d5f21
1739785brivaracetam 10 MG per 1 ML Oral SolutionSYaef3ee92-e2a6-4135-94b2-b893f893d5f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72673-031-10726730031101 BOTTLE in 1 CARTON (72673-031-10) / 300 mL in 1 BOTTLE1 bottle2026-02-21NoNoCurrent