NDC 72694-515

asparlas

Calaspargase Pegol

asparlas is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Servier Pharmaceuticals Llc. The primary component is Calaspargase Pegol.

• Product ID: 72694-515_25fc7d15-4a8f-4c12-a603-aeeac73e4998
• NDC: 72694-515
• Product Type: Human Prescription Drug
• Proprietary Name: asparlas
• Generic Name: Calaspargase Pegol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-09-27
• Marketing Category: BLA / BLA
• Application Number: BLA761102
• Labeler Name: Servier Pharmaceuticals LLC
• Substance Name: CALASPARGASE PEGOL
• Active Ingredient Strength: 750 U/mL
• Pharm Classes: Asparaginase [CS],Asparagine-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 72694-515-01

1 VIAL, SINGLE-USE in 1 CARTON (72694-515-01) > 5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2019-09-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72694-515-01 [72694051501]

asparlas INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761102
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-27

Drug Details

Active Ingredients

Ingredient	Strength
CALASPARGASE PEGOL	750 U/mL

OpenFDA Data

• SPL SET ID: 6585bd0d-bd78-4341-9e87-0f7664821f05
• Manufacturer:
  • Servier Pharmaceuticals LLC
• UNII:
  • T9FVH03HMZ
• RxNorm Concept Unique ID - RxCUI:
  • 2121421
  • 2121426
• UPC Code:
  • 0372694515017

Pharmacological Class

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