FDA.reportPublic FDA data

KEYTRUDA QLEX

Product NDC
0006-5083
11-digit product format
000065083
Labeler code
0006
Product ID
0006-5083_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

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
application number: BLA761467
ndc (product): 0006-5083

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
0006-5083-01KEYTRUDA QLEX1 in 1 CARTONINJECTION, SOLUTION114
0006-5083-99KEYTRUDA QLEX4.8 mL in 1 VIALINJECTION, SOLUTION4.814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5083-01ML - Milliliter0006-50837eaad2f8-3b99-4cbf-bd5c-60969251745312025-10-14
0006-5083-99ML - Milliliter0006-508324d60c39-48d3-434e-921f-3e6d1f4cff1e12025-10-14

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

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
0006-5083-01000065083011 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99) 1 vial2025-09-19NoNoCurrent
0006-5083-99000065083994.8 mL in 1 VIAL4.8 mlHistorical