NDC 0944-3810

ONCASPAR

Pegaspargase

ONCASPAR is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxalta Us Inc.. The primary component is Pegaspargase.

Product ID0944-3810_5b739c5e-49a1-48f5-9788-b407217a9a97
NDC0944-3810
Product TypeHuman Prescription Drug
Proprietary NameONCASPAR
Generic NamePegaspargase
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1994-02-01
Marketing CategoryBLA / BLA
Application NumberBLA103411
Labeler NameBaxalta US Inc.
Substance NamePEGASPARGASE
Active Ingredient Strength750 [iU]/mL
Pharm ClassesAsparaginase [CS],Asparagine-specific Enzyme [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0944-3810-01

1 VIAL, SINGLE-USE in 1 CARTON (0944-3810-01) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date1994-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0944-3810-01 [00944381001]

ONCASPAR INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103411
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-02-01
Marketing End Date2020-05-16

Drug Details

Active Ingredients

IngredientStrength
PEGASPARGASE750 [iU]/mL

OpenFDA Data

SPL SET ID:7fc3d37f-df69-484f-9ab1-7ba1c4947898
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213040
  • 240906
  • Pharmacological Class

    • Asparaginase [CS]
    • Asparagine-specific Enzyme [EPC]

    NDC Crossover Matching brand name "ONCASPAR" or generic name "Pegaspargase"

    NDCBrand NameGeneric Name
    0944-3810ONCASPARPegaspargase
    72694-954ONCASPARPegaspargase

    Trademark Results [ONCASPAR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ONCASPAR
    ONCASPAR
    79384548 not registered Live/Pending
    SERVIER IP UK LIMITED
    2023-10-16
    ONCASPAR
    ONCASPAR
    74278090 1809883 Live/Registered
    SERVIER IP UK LIMITED
    1992-05-26

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