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
BERAHYALURONIDASE ALFA2000 U/mL
PEMBROLIZUMAB165 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDPT0O3T46P, 9X4R4A4HQQ
Rxcui2723762, 2723769, 2723771, 2723772

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

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 vial2025-09-19NoNoHistorical
0006-3083-99000063083992.4 mL in 1 VIAL2.4 mlHistorical