FDA.reportPublic FDA data

1 ML palivizumab 100 MG/ML Injection [Synagis]

RxCUI
1657343
RxNorm name
1 ML palivizumab 100 MG/ML Injection [Synagis]
Display name
1 ML palivizumab 100 MG/ML Injection [Synagis]
Full name
1 ML palivizumab 100 MG/ML Injection [Synagis]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103770Synagispalivizumab351(a)Disc2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SynagisPALIVIZUMABSwedish Orphan Biovitrum AB (publ)3a0096c7-8139-44cd-bba4-520ab05c2cb22026-01-21Warnings, Adverse reactionsExact identifier
rxcui: 1657343

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3a0096c7-8139-44cd-bba4-520ab05c2cb2Synagis 100 MG in 1 ML Injection [PSN] · 1 ML palivizumab 100 MG/ML Injection [Synagis] [SBD] · Synagis 100 MG per 1 ML Injection [SY]38These highlights do not include all the information needed to use SYNAGIS safely and effectively. See full prescribing information for SYNAGIS. SYNAGIS ® (palivizumab) injection, for intramuscular use Initial U.S. Approval: 199820260121