Home NDC 60574-4114 Synagis
Product NDC 60574-4114
11-digit product format 605744114
Labeler code 60574
Product ID 60574-4114_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 1999-12-09
Marketing end 0000-00-00
Substance PALIVIZUMAB
Active strength 50 mg/.5mL
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 · 24 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 60574-4114-1 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 60574-4114-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 60574-4114-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 60574-4114-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 60574-4114-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 60574-4114-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 60574-4114-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 60574-4114-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 60574-4114-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 60574-4114-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 60574-4114-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 60574-4114-1 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 Marketing start Marketing end Sample Exclude flag Status 60574-4114-1 60574411401 .5 mL in 1 VIAL, SINGLE-DOSE (60574-4114-1) 2005-09-28 0000-00-00 No No Current