NDC 0004-0350

Pegasys

Peginterferon Alfa-2a

Pegasys is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Peginterferon Alfa-2a.

• Product ID: 0004-0350_1c0c1a2c-a7a6-4fde-b801-8e4fda99cfe1
• NDC: 0004-0350
• Product Type: Human Prescription Drug
• Proprietary Name: Pegasys
• Generic Name: Peginterferon Alfa-2a
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2002-10-16
• Marketing Category: BLA / BLA
• Application Number: BLA103964
• Labeler Name: Genentech, Inc.
• Substance Name: PEGINTERFERON ALFA-2A
• Active Ingredient Strength: 180 ug/mL
• Pharm Classes: Interferon alpha [EPC],Interferon-alpha [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0004-0350-09

1 VIAL, SINGLE-USE in 1 BOX (0004-0350-09) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2002-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0004-0350-39 [00004035039]

Pegasys INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103964
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-10-16
• Marketing End Date: 2009-09-01

NDC 0004-0350-09 [00004035009]

Pegasys INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103964
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-10-16

Drug Details

Active Ingredients

Ingredient	Strength
PEGINTERFERON ALFA-2A	180 ug/mL

OpenFDA Data

• SPL SET ID: de61685e-2b8c-4e22-84bb-869e13600440
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • Q46947FE7K
• RxNorm Concept Unique ID - RxCUI:
  • 1650940
  • 1650922
  • 351270
  • 352297
  • 1650896
  • 1650894
  • 731326
  • 731328

Pharmacological Class

• Interferon alpha [EPC]
• Interferon-alpha [CS]

NDC Crossover Matching brand name "Pegasys" or generic name "Peginterferon Alfa-2a"

NDC	Brand Name	Generic Name
0004-0350	Pegasys	peginterferon alfa-2a
0004-0357	Pegasys	peginterferon alfa-2a
0004-0365	Pegasys	peginterferon alfa-2a
82154-0449	Pegasys	peginterferon alfa-2a
82154-0451	Pegasys	peginterferon alfa-2a