FDA.reportPublic FDA data

KEYTRUDA QLEX

Product NDC
0006-3083
11-digit product format
000063083
Labeler code
0006
Product ID
0006-3083_14534d8e-3733-4444-862e-5bf5a751c83a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pembrolizumab and berahyaluronidase alfa-pmph
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Merck Sharp & Dohme LLC
Application
BLA761467
Marketing category
BLA
Marketing start
2025-09-19
Substance
BERAHYALURONIDASE ALFA; PEMBROLIZUMAB
Active strength
2000; 165 U/mL; mg/mL
Pharmacologic classes
Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KEYTRUDA QLEX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMBROLIZUMAB2000 U/mL
BERAHYALURONIDASE ALFA165 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9X4R4A4HQQInternal UNII lookup
DPT0O3T46PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2723762Internal RxNorm lookup
2723769Internal RxNorm lookup
2723771Internal RxNorm lookup
2723772Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
097d166f-b73b-41d3-9b37-7653cd2a0c41Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8e8f9c11-8c94-4615-8579-57b2877ce51bProduct name120150325
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3083-01KEYTRUDA QLEX1 in 1 CARTONINJECTION, SOLUTION114
0006-3083-99KEYTRUDA QLEX2.4 mL in 1 VIALINJECTION, SOLUTION2.414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3083-01ML - Milliliter0006-30835d2bb98c-1606-4cb9-b401-9bf6670647d512025-10-14
0006-3083-99ML - Milliliter0006-3083ec67f8e6-b32d-47e5-b28c-3bed1073bd4312025-10-14

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
application number: BLA761467
ndc (product): 0006-3083

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723769Keytruda Qlex 395 MG / 4800 UNT in 2.4 ML InjectionPSN097d166f-b73b-41d3-9b37-7653cd2a0c4114
2723772Keytruda Qlex 790 MG / 9600 UNT in 4.8 ML InjectionPSN097d166f-b73b-41d3-9b37-7653cd2a0c4114
2723762pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT in 2.4 ML InjectionPSN097d166f-b73b-41d3-9b37-7653cd2a0c4114
2723771pembrolizumab-pmph 790 MG / berahyaluronidase alfa-pmph 9600 UNT in 4.8 ML InjectionPSN097d166f-b73b-41d3-9b37-7653cd2a0c4114
27237692.4 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML Injection [Keytruda Qlex]SBD097d166f-b73b-41d3-9b37-7653cd2a0c4114
27237724.8 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML Injection [Keytruda Qlex]SBD097d166f-b73b-41d3-9b37-7653cd2a0c4114
27237622.4 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML InjectionSCD097d166f-b73b-41d3-9b37-7653cd2a0c4114
27237714.8 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML InjectionSCD097d166f-b73b-41d3-9b37-7653cd2a0c4114
2723769Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph 395 MG / 4800 UNT) per 2.4 ML InjectionSY097d166f-b73b-41d3-9b37-7653cd2a0c4114
2723772Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph 790 MG / 9600 UNT) per 4.8 ML InjectionSY097d166f-b73b-41d3-9b37-7653cd2a0c4114
2723762pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML InjectionSY097d166f-b73b-41d3-9b37-7653cd2a0c4114
2723771pembrolizumab-pmph 790 MG / berahyaluronidase alfa-pmph 9600 UNT per 4.8 ML InjectionSY097d166f-b73b-41d3-9b37-7653cd2a0c4114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0006-3083-01000063083011 VIAL in 1 CARTON (0006-3083-01) / 2.4 mL in 1 VIAL (0006-3083-99) 1 vial2025-09-19NoNoCurrent
0006-3083-99000063083992.4 mL in 1 VIAL2.4 mlHistorical