Home NDC 66658-230 Synagis
Product NDC 66658-230
11-digit product format 666580230
Labeler code 66658
Product ID 66658-230_48e6af70-cd93-3f1d-e063-6394a90a8104
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name palivizumab
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Swedish Orphan Biovitrum AB (publ)
Application BLA103770
Marketing category BLA
Marketing start 1999-12-09
Marketing end 2026-09-30
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
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Synagis Active Ingredients# Ingredient, Strength table Ingredient Strength PALIVIZUMAB 50 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DQ448MW7KS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1657341 Internal RxNorm lookup 1657343 Internal RxNorm lookup 1657361 Internal RxNorm lookup 1657362 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66658-230-01 Synagis 0.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 0.5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66658-230 SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 5 Current NDC, Legacy NDC, 1 package rows 20220329_3a0096c7-8139-44cd-bba4-520ab05c2cb2.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.
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 66658-230-01 66658023001 .5 mL in 1 VIAL, SINGLE-DOSE (66658-230-01) 2005-09-28 2026-09-30 No No Current