Pegasys

Product NDC
0004-0350
11-digit product format
000040350
Labeler code
0004
Product ID
0004-0350_cc1e24aa-6242-4429-bfeb-c92907641f3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
peginterferon alfa-2a
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA103964
Marketing category
BLA
Marketing start
2002-10-16
Marketing end
2025-06-30
Substance
PEGINTERFERON ALFA-2A
Active strength
180 ug/mL
Pharmacologic classes
Interferon alpha [EPC], Interferon-alpha [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0350-09ML - Milliliter0004-0350fa44af98-4dc0-4cd9-a405-9cecd89e14cc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
peginterferon alfa-2aACTIVE INGREDIENTQ46947FE7KPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
peginterferon alfa-2aACTIVE MOIETYQ46947FE7KPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
acetic acidINACTIVE INGREDIENTQ40Q9N063PPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
AlcoholINACTIVE INGREDIENT3K9958V90MPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
sodium acetateINACTIVE INGREDIENT4550K0SC9BPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
talcINACTIVE INGREDIENT7SEV7J4R1UPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26
waterINACTIVE INGREDIENT059QF0KO0RPEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0004-0350PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]38Legacy NDC20221214_de61685e-2b8c-4e22-84bb-869e13600440.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0004-0350-09000040350091 VIAL, SINGLE-USE in 1 BOX (0004-0350-09) > 1 mL in 1 VIAL, SINGLE-USE2002-10-160000-00-00NoNoCurrent