Home NDC 60574-4113-1 Synagis
Product NDC 60574-4113
Requested package NDC 60574-4113-1
11-digit product format 605744113
Labeler code 60574
Product ID 60574-4113_14cf114d-3f1e-485b-83f3-61d88c3c1a98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name palivizumab
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler MedImmune, LLC
Application BLA103770
Marketing category BLA
Marketing start 1998-06-19
Marketing end 0000-00-00
Substance PALIVIZUMAB
Active strength 100 mg/mL
Pharmacologic classes Antibodies, Monoclonal [CS],Fusion Protein Inhibitors [MoA],Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PALIVIZUMAB ACTIVE INGREDIENT DQ448MW7KS SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [MEDIMMUNE, LLC] 28 PALIVIZUMAB ACTIVE MOIETY DQ448MW7KS SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [MEDIMMUNE, LLC] 28 CHLORIDE ION INACTIVE INGREDIENT Q32ZN48698 SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [MEDIMMUNE, LLC] 28 GLYCINE INACTIVE INGREDIENT TE7660XO1C SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [MEDIMMUNE, LLC] 28 HISTIDINE INACTIVE INGREDIENT 4QD397987E SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [MEDIMMUNE, LLC] 28
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 Synagis PALIVIZUMAB Swedish Orphan Biovitrum AB (publ) 3a0096c7-8139-44cd-bba4-520ab05c2cb2 2026-01-21 Warnings, Adverse reactions Exact identifier application number: BLA103770
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103770 Synagis palivizumab 351(a) Disc 2026-07-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60574-4113-1 60574411301 1 mL in 1 VIAL, SINGLE-DOSE (60574-4113-1) 1 ml 2005-09-28 0000-00-00 No No Current