NDC 57902-249

ERWINAZE

Asparaginase

ERWINAZE is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Asparaginase Erwinia Chrysanthemi.

Product ID57902-249_4da45931-b925-4f47-9cf1-4fcfb12c5b29
NDC57902-249
Product TypeHuman Prescription Drug
Proprietary NameERWINAZE
Generic NameAsparaginase
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2011-11-18
Marketing CategoryBLA / BLA
Application NumberBLA125359
Labeler NameJazz Pharmaceuticals, Inc.
Substance NameASPARAGINASE ERWINIA CHRYSANTHEMI
Active Ingredient Strength10000 [iU]/mL
Pharm ClassesAsparaginase [CS],Asparagine-specific Enzyme [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57902-249-05

5 VIAL, GLASS in 1 CARTON (57902-249-05) > 1 mL in 1 VIAL, GLASS (57902-249-01)
Marketing Start Date2011-11-18
Marketing End Date2021-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57902-249-05 [57902024905]

ERWINAZE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125359
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-18

NDC 57902-249-01 [57902024901]

ERWINAZE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125359
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-18

Drug Details

Active Ingredients

IngredientStrength
ASPARAGINASE ERWINIA CHRYSANTHEMI10000 [iU]/mL

OpenFDA Data

SPL SET ID:30bdf2ea-008b-4cbb-81e4-c3474f2ad286
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 150889
  • 1232190
  • Pharmacological Class

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

    NDC Crossover Matching brand name "ERWINAZE" or generic name "Asparaginase"

    NDCBrand NameGeneric Name
    57902-249ERWINAZEAsparaginase
    81561-413ERWINASEasparaginase

    Trademark Results [ERWINAZE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ERWINAZE
    ERWINAZE
    90081574 not registered Live/Pending
    Porton Biopharma Limited
    2020-07-29
    ERWINAZE
    ERWINAZE
    85245951 4147569 Live/Registered
    PORTON BIOPHARMA LIMITED
    2011-02-18
    ERWINAZE
    ERWINAZE
    85031446 not registered Dead/Abandoned
    EUSA Pharma (Europe) Limited
    2010-05-06

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