Home NDC 0004-0357-30 Pegasys
Product NDC 0004-0357
Requested package NDC 0004-0357-30
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 0004-0357 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 Units Marketing start Marketing end Sample Exclude flag Status 0004-0357-30 00004035730 1 PACKET in 1 BOX (0004-0357-30) > 4 SYRINGE, GLASS in 1 PACKET > .5 mL in 1 SYRINGE, GLASS 1 packet 2011-03-29 2024-06-30 No No Current