Brivaracetam Oral Solution

Product NDC
67877-904
11-digit product format
678770904
Labeler code
67877
Product ID
67877-904_83ea212f-3496-4230-bf18-02bd6c82038f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brivaracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA219772
Marketing category
ANDA
Marketing start
2026-02-23
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 Oral Solution
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
67877-904-58Brivaracetam Oral Solution300 mL in 1 BOTTLESOLUTION3005
67877-904-58Brivaracetam Oral Solution1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-904-58ML - Milliliter67877-904681a5582-0a5f-47da-b1e5-cec28680469a12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739785brivaracetam 10 MG in 1 mL Oral SolutionPSNc4ee9b82-1067-4efc-b3d9-f24eb0c461d55
1739785brivaracetam 10 MG/ML Oral SolutionSCDc4ee9b82-1067-4efc-b3d9-f24eb0c461d55
1739785brivaracetam 10 MG per 1 ML Oral SolutionSYc4ee9b82-1067-4efc-b3d9-f24eb0c461d55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-904-58678770904581 BOTTLE in 1 CARTON (67877-904-58) / 300 mL in 1 BOTTLE1 bottle2026-02-23NoNoHistorical