FDA.reportPublic FDA data

Palynziq 2.5 MG per 0.5 ML Prefilled Syringe

RxCUI
2046376
RxNorm name
Palynziq 2.5 MG per 0.5 ML Prefilled Syringe
Display name
Palynziq 2.5 MG per 0.5 ML Prefilled Syringe
Full name
Palynziq 2.5 MG per 0.5 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761079Palynziqpegvaliase-pqpz351(a)Rx2026-08-01

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
PalynziqPEGVALIASE-PQPZBioMarin Pharmaceutical Inc.6dba844a-db02-44f8-8593-ce497ed9406c2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2046376

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
6dba844a-db02-44f8-8593-ce497ed9406cPalynziq 2.5 MG in 0.5 mL Prefilled Syringe [PSN] · 0.5 ML pegvaliase-pqpz 5 MG/ML Prefilled Syringe [Palynziq] [SBD] · 0.5 ML Palynziq 5 MG/ML Prefilled Syringe [SY] · Palynziq 2.5 MG per 0.5 ML Prefilled Syringe [SY]436These highlights do not include all the information needed to use PALYNZIQ safely and effectively. See full prescribing information for PALYNZIQ. PALYNZIQ (pegvaliase-pqpz) injection, for subcutaneous use Initial U.S. Approval: 201820260302