NDC 50474-570

Briviact

Brivaracetam

Briviact is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ucb, Inc.. The primary component is Brivaracetam.

Product ID50474-570_708cf16b-de7e-4987-86b4-84c1ca71b76c
NDC50474-570
Product TypeHuman Prescription Drug
Proprietary NameBriviact
Generic NameBrivaracetam
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-05-12
Marketing CategoryNDA / NDA
Application NumberNDA205836
Labeler NameUCB, Inc.
Substance NameBRIVARACETAM
Active Ingredient Strength50 mg/1
Pharm ClassesEpoxide Hydrolase Inhibitors [MoA]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50474-570-09

100 BLISTER PACK in 1 CARTON (50474-570-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2016-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50474-570-09 [50474057009]

Briviact TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205836
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-12

NDC 50474-570-12 [50474057012]

Briviact TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-12
Marketing End Date2019-03-22

NDC 50474-570-14 [50474057014]

Briviact TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-12

NDC 50474-570-66 [50474057066]

Briviact TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205836
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-12

Drug Details

Active Ingredients

IngredientStrength
BRIVARACETAM50 mg/1

OpenFDA Data

SPL SET ID:3cf2f439-0e97-443e-8e33-25ecef616f6c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1739774
  • 1739761
  • 1739766
  • 1739770
  • 1739772
  • 1739785
  • 1739768
  • 1739780
  • 1739778
  • 1739782
  • 1739749
  • 1739776
  • 1739788
  • 1739754
  • Pharmacological Class

    • Epoxide Hydrolase Inhibitors [MoA]
    • Epoxide Hydrolase Inhibitors [MoA]

    Medicade Reported Pricing

    50474057066 BRIVIACT 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    50474057009 BRIVIACT 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Briviact" or generic name "Brivaracetam"

    NDCBrand NameGeneric Name
    50474-370Briviactbrivaracetam
    50474-470Briviactbrivaracetam
    50474-570Briviactbrivaracetam
    50474-670Briviactbrivaracetam
    50474-770Briviactbrivaracetam
    50474-870Briviactbrivaracetam
    50474-970Briviactbrivaracetam

    Trademark Results [Briviact]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BRIVIACT
    BRIVIACT
    97864286 not registered Live/Pending
    UCB Biopharma SRL
    2023-03-30
    BRIVIACT
    BRIVIACT
    79172779 5000660 Live/Registered
    UCB Biopharma SPRL
    2015-07-27
    BRIVIACT
    BRIVIACT
    79111360 4228485 Live/Registered
    UCB Biopharma SPRL
    2011-12-21

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.