FDA.reportPublic FDA data

pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML Injection

RxCUI
2723762
RxNorm name
pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML Injection
Display name
pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML Injection
Full name
pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761467Keytruda Qlexpembrolizumab and berahyaluronidase alfa-pmph351(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
KEYTRUDA QLEXPEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPHMerck Sharp & Dohme LLC097d166f-b73b-41d3-9b37-7653cd2a0c412026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 2723762

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
097d166f-b73b-41d3-9b37-7653cd2a0c41pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT in 2.4 ML Injection [PSN] · 2.4 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML Injection [SCD] · pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML Injection [SY]314These highlights do not include all the information needed to use KEYTRUDA QLEX safely and effectively. See full prescribing information for KEYTRUDA QLEX. KEYTRUDA QLEX ™ (pembrolizumab and berahyaluronidase alfa-pmph) injection, for subcutaneous use Initial U.S. Approval: 202520260512