FDA.reportPublic FDA data

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph 790 MG / 9600 UNT) per 4.8 ML Injection

RxCUI
2723772
RxNorm name
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph 790 MG / 9600 UNT) per 4.8 ML Injection
Display name
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph 790 MG / 9600 UNT) per 4.8 ML Injection
Full name
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph 790 MG / 9600 UNT) per 4.8 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: 2723772

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
097d166f-b73b-41d3-9b37-7653cd2a0c41Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph 790 MG / 9600 UNT) per 4.8 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-41d3-9b37-7653cd2a0c41Keytruda Qlex 790 MG / 9600 UNT in 4.8 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-41d3-9b37-7653cd2a0c414.8 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML Injection [Keytruda Qlex]SBD14These 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