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 ID: 0944-3810_5b739c5e-49a1-48f5-9788-b407217a9a97
• NDC: 0944-3810
• Product Type: Human Prescription Drug
• Proprietary Name: ONCASPAR
• Generic Name: Pegaspargase
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 1994-02-01
• Marketing Category: BLA / BLA
• Application Number: BLA103411
• Labeler Name: Baxalta US Inc.
• Substance Name: PEGASPARGASE
• Active Ingredient Strength: 750 [iU]/mL
• Pharm Classes: Asparaginase [CS],Asparagine-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0944-3810-01

1 VIAL, SINGLE-USE in 1 CARTON (0944-3810-01) > 5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1994-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0944-3810-01 [00944381001]

ONCASPAR INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103411
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1994-02-01
• Marketing End Date: 2020-05-16

Drug Details

Active Ingredients

Ingredient	Strength
PEGASPARGASE	750 [iU]/mL

OpenFDA Data

• SPL SET ID: 7fc3d37f-df69-484f-9ab1-7ba1c4947898
• Manufacturer:
  • Baxalta US Inc.
• UNII:
  • 7D96IR0PPM
• 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"

NDC	Brand Name	Generic Name
0944-3810	ONCASPAR	Pegaspargase
72694-954	ONCASPAR	Pegaspargase