brivaracetam

Product NDC
72205-033
11-digit product format
722050033
Labeler code
72205
Product ID
72205-033_dca92c5b-78a8-4ee1-9f06-18320ae2a2e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brivaracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214922
Marketing category
ANDA
Marketing start
2026-02-19
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
72205-033-73brivaracetam300 mL in 1 BOTTLESOLUTION3001
72205-033-73brivaracetam1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-033-73ML - Milliliter72205-03342708479-1dd9-491e-a6d5-6f8e569ffb1212026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739785brivaracetam 10 MG in 1 mL Oral SolutionPSNdca92c5b-78a8-4ee1-9f06-18320ae2a2e81
1739785brivaracetam 10 MG/ML Oral SolutionSCDdca92c5b-78a8-4ee1-9f06-18320ae2a2e81
1739785brivaracetam 10 MG per 1 ML Oral SolutionSYdca92c5b-78a8-4ee1-9f06-18320ae2a2e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-033-73722050033731 BOTTLE in 1 CARTON (72205-033-73) / 300 mL in 1 BOTTLE1 bottle2026-02-19NoNoCurrent