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 ID: 57902-249_4da45931-b925-4f47-9cf1-4fcfb12c5b29
• NDC: 57902-249
• Product Type: Human Prescription Drug
• Proprietary Name: ERWINAZE
• Generic Name: Asparaginase
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2011-11-18
• Marketing Category: BLA / BLA
• Application Number: BLA125359
• Labeler Name: Jazz Pharmaceuticals, Inc.
• Substance Name: ASPARAGINASE ERWINIA CHRYSANTHEMI
• Active Ingredient Strength: 10000 [iU]/mL
• Pharm Classes: Asparaginase [CS],Asparagine-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2011-11-18
• Marketing End Date: 2021-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57902-249-05 [57902024905]

ERWINAZE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125359
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-11-18

NDC 57902-249-01 [57902024901]

ERWINAZE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125359
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-11-18

Drug Details

Active Ingredients

Ingredient	Strength
ASPARAGINASE ERWINIA CHRYSANTHEMI	10000 [iU]/mL

OpenFDA Data

• SPL SET ID: 30bdf2ea-008b-4cbb-81e4-c3474f2ad286
• Manufacturer:
  • Jazz Pharmaceuticals, Inc.
• UNII:
  • D733ET3F9O
• 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"

NDC	Brand Name	Generic Name
57902-249	ERWINAZE	Asparaginase
81561-413	ERWINASE	asparaginase