Brivaracetam

Product NDC
72205-272
11-digit product format
722050272
Labeler code
72205
Product ID
72205-272_2c6af271-3222-4602-98a6-14754f0a29ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brivaracetam
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214924
Marketing category
ANDA
Marketing start
2026-02-23
Substance
BRIVARACETAM
Active strength
50 mg/5mL
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
BRIVARACETAM50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU863JGG2IA
Rxcui1739749

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
1447c696-6954-40c0-b275-6f6c780ca8b7Product name120160323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-272-01Brivaracetam5 mL in 1 VIAL, GLASSINJECTION, SOLUTION51
72205-272-07Brivaracetam10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-272-01ML - Milliliter72205-2720331720d-e506-4930-887a-e3293bf897fc12026-03-17
72205-272-07ML - Milliliter72205-272173fedb4-0f5f-4adb-bbf1-d4eb0224a35212026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739749brivaracetam 50 MG in 5 ML InjectionPSN2c6af271-3222-4602-98a6-14754f0a29ba1
17397495 ML brivaracetam 10 MG/ML InjectionSCD2c6af271-3222-4602-98a6-14754f0a29ba1
1739749brivaracetam 50 MG per 5 ML InjectionSY2c6af271-3222-4602-98a6-14754f0a29ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-272-01722050272015 mL in 1 VIAL, GLASS5 mlHistorical
72205-272-077220502720710 VIAL, GLASS in 1 CARTON (72205-272-07) / 5 mL in 1 VIAL, GLASS (72205-272-01) 2026-02-23NoNoCurrent