Home NDC 0004-0350-09 Pegasys
Product NDC 0004-0350
Requested package NDC 0004-0350-09
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0004-0350 0004-0350-09 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0004-0350 0004-0350-09 D Discontinued by firm excluded / ndc_excluded.zip 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
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 2026-10-01
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 2025-06-30 No No Current