Brivaracetam oral Solution

Product NDC
71921-410
11-digit product format
719210410
Labeler code
71921
Product ID
71921-410_7957cc22-2e0f-489d-9fa1-99520f615934
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brivaracetam oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA220385
Marketing category
ANDA
Marketing start
2026-02-24
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71921-410-72Brivaracetam oral Solution1 in 1 CARTONSOLUTION11
71921-410-72Brivaracetam oral Solution300 mL in 1 BOTTLESOLUTION3001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-410-72ML - Milliliter71921-41087bfccd2-f7ab-43b9-99b7-aa48e1a8ed5112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739785brivaracetam 10 MG in 1 mL Oral SolutionPSN7957cc22-2e0f-489d-9fa1-99520f6159341
1739785brivaracetam 10 MG/ML Oral SolutionSCD7957cc22-2e0f-489d-9fa1-99520f6159341
1739785brivaracetam 10 MG per 1 ML Oral SolutionSY7957cc22-2e0f-489d-9fa1-99520f6159341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-410-72719210410721 BOTTLE in 1 CARTON (71921-410-72) / 300 mL in 1 BOTTLE1 bottle2026-02-24NoNoHistorical