FDA.reportPublic FDA data

Pegasys

Product NDC
0004-0365
11-digit product format
000040365
Labeler code
0004
Product ID
0004-0365_dcb3ce3c-0f68-4076-88b3-4ee8d818081b
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
2011-11-01
Marketing end
0000-00-00
Substance
PEGINTERFERON ALFA-2A
Active strength
180 ug/.5mL
Pharmacologic classes
Interferon alpha [EPC],Interferon-alpha [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0004-0365DDiscontinued by firm2026-07-31
excluded packagepackage0004-03650004-0365-09DDiscontinued by firm2026-07-31
excluded packagepackage0004-03650004-0365-30DDiscontinued 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
0004-0365-30ML - Milliliter0004-03653765b011-6a95-41d4-b6bf-217e742f84df12012-07-24

Purple Book Biologic Products#

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