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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-41d3-9b37-7653cd2a0c412026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 2723762

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
097d166f-b73b-41d3-9b37-7653cd2a0c41pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML InjectionSY14These 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
097d166f-b73b-41d3-9b37-7653cd2a0c41pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT in 2.4 ML InjectionPSN14These 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
097d166f-b73b-41d3-9b37-7653cd2a0c412.4 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML InjectionSCD14These 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