Home NDC 0004-0350 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0004-0350-09 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0004-0350-09 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded peginterferon alfa-2a ACTIVE INGREDIENT Q46947FE7K PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 peginterferon alfa-2a ACTIVE MOIETY Q46947FE7K PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 acetic acid INACTIVE INGREDIENT Q40Q9N063P PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 Alcohol INACTIVE INGREDIENT 3K9958V90M PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 sodium acetate INACTIVE INGREDIENT 4550K0SC9B PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 sodium chloride INACTIVE INGREDIENT 451W47IQ8X PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 talc INACTIVE INGREDIENT 7SEV7J4R1U PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26 water INACTIVE INGREDIENT 059QF0KO0R PEGASYS (PEGINTERFERON ALFA-2A) KIT PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0004-0350 PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [GENENTECH, INC.] 38 Legacy NDC 20221214_de61685e-2b8c-4e22-84bb-869e13600440.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pegasys PEGINTERFERON ALFA-2A pharmaand GmbH d9290e5b-6d40-2318-e053-2995a90a9916 2026-09-02 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103964
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103964 Pegasys peginterferon alfa-2a 351(a) Rx 2026-09-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0004-0350-09 00004035009 1 VIAL, SINGLE-USE in 1 BOX (0004-0350-09) > 1 mL in 1 VIAL, SINGLE-USE 2002-10-16 0000-00-00 No No Current