NDC 68135-058

Palynziq

Pegvaliase-pqpz

Palynziq is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Biomarin Pharmaceutical Inc.. The primary component is Pegvaliase.

Product ID68135-058_13686fc1-3709-4731-9500-dd9d53a48d12
NDC68135-058
Product TypeHuman Prescription Drug
Proprietary NamePalynziq
Generic NamePegvaliase-pqpz
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-05-24
Marketing CategoryBLA / BLA
Application NumberBLA761079
Labeler NameBioMarin Pharmaceutical Inc.
Substance NamePEGVALIASE
Active Ingredient Strength3 mg/.5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68135-058-90

1 SYRINGE in 1 CARTON (68135-058-90) > .5 mL in 1 SYRINGE (68135-058-89)
Marketing Start Date2018-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68135-058-89 [68135005889]

Palynziq INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761079
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-24

NDC 68135-058-90 [68135005890]

Palynziq INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761079
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-24

Drug Details

Active Ingredients

IngredientStrength
PEGVALIASE2.5 mg/.5mL

OpenFDA Data

SPL SET ID:6dba844a-db02-44f8-8593-ce497ed9406c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2046379
  • 2046370
  • 2046374
  • 2046376
  • 2046365
  • 2046380
  • NDC Crossover Matching brand name "Palynziq" or generic name "Pegvaliase-pqpz"

    NDCBrand NameGeneric Name
    68135-058Palynziqpegvaliase-pqpz
    68135-673Palynziqpegvaliase-pqpz
    68135-756Palynziqpegvaliase-pqpz

    Trademark Results [Palynziq]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PALYNZIQ
    PALYNZIQ
    87978318 5577454 Live/Registered
    Biomarin Pharmaceutical Inc.
    2017-07-05
    PALYNZIQ
    PALYNZIQ
    87516947 not registered Live/Pending
    Biomarin Pharmaceutical Inc.
    2017-07-05
    PALYNZIQ
    PALYNZIQ
    87516646 not registered Live/Pending
    Biomarin Pharmaceutical Inc.
    2017-07-05
    PALYNZIQ
    PALYNZIQ
    87516640 5576853 Live/Registered
    Biomarin Pharmaceutical Inc.
    2017-07-05
    PALYNZIQ
    PALYNZIQ
    87095019 5581302 Live/Registered
    Biomarin Pharmaceutical Inc.
    2016-07-06

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