FDA.reportPublic FDA data

Pegasys

Product NDC
0004-0357
11-digit product format
000040357
Labeler code
0004
Product ID
0004-0357_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
2011-03-29
Marketing end
2024-06-30
Substance
PEGINTERFERON ALFA-2A
Active strength
180 ug/.5mL
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0004-0357DDiscontinued by firm2026-07-31
excluded packagepackage0004-03570004-0357-30DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PegasysPEGINTERFERON ALFA-2Apharmaand GmbHd9290e5b-6d40-2318-e053-2995a90a99162026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103964

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0357-30ML - Milliliter0004-035799435df1-951f-482c-b878-5329f6f6c25912012-07-24

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
0004-0357PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.]38Legacy NDC20221214_de61685e-2b8c-4e22-84bb-869e13600440.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103964Pegasyspeginterferon alfa-2a351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0004-0357-30000040357301 PACKET in 1 BOX (0004-0357-30) > 4 SYRINGE, GLASS in 1 PACKET > .5 mL in 1 SYRINGE, GLASS1 packet2011-03-290000-00-00NoNoCurrent