keytruda qlex

Generic: pembrolizumab and berahyaluronidase alfa-pmph

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name keytruda qlex
Generic Name pembrolizumab and berahyaluronidase alfa-pmph
Labeler merck sharp & dohme llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

berahyaluronidase alfa 2000 U/mL, pembrolizumab 165 mg/mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5083
Product ID 0006-5083_101736d1-6faf-42b3-803e-4efd52ff4b6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761467
Listing Expiration 2027-12-31
Marketing Start 2025-09-19

Pharmacologic Class

Established (EPC)
programmed death receptor-1 blocking antibody [epc] endoglycosidase [epc]
Mechanism of Action
programmed death receptor-1-directed antibody interactions [moa]
Chemical Structure
glycoside hydrolases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065083
Hyphenated Format 0006-5083

Supplemental Identifiers

RxCUI
2723762 2723769 2723771 2723772
UNII
DPT0O3T46P 9X4R4A4HQQ
NUI
N0000191260 N0000191259 N0000175531 M0009499

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name keytruda qlex (source: ndc)
Generic Name pembrolizumab and berahyaluronidase alfa-pmph (source: ndc)
Application Number BLA761467 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2000 U/mL
  • 165 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99)
source: ndc

Packages (1)

0006-5083-01 1 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99)

Ingredients (2)

berahyaluronidase alfa (2000 U/mL) pembrolizumab (165 mg/mL)

Linked Drug Pages (1)

KEYTRUDA QLEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "101736d1-6faf-42b3-803e-4efd52ff4b6c", "openfda": {"nui": ["N0000191260", "N0000191259", "N0000175531", "M0009499"], "unii": ["DPT0O3T46P", "9X4R4A4HQQ"], "rxcui": ["2723762", "2723769", "2723771", "2723772"], "spl_set_id": ["097d166f-b73b-41d3-9b37-7653cd2a0c41"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["Programmed Death Receptor-1 Blocking Antibody [EPC]", "Endoglycosidase [EPC]"], "pharm_class_moa": ["Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0006-5083-01)  / 4.8 mL in 1 VIAL (0006-5083-99)", "package_ndc": "0006-5083-01", "marketing_start_date": "20250919"}], "brand_name": "KEYTRUDA QLEX", "product_id": "0006-5083_101736d1-6faf-42b3-803e-4efd52ff4b6c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]", "Programmed Death Receptor-1 Blocking Antibody [EPC]", "Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "product_ndc": "0006-5083", "generic_name": "pembrolizumab and berahyaluronidase alfa-pmph", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KEYTRUDA QLEX", "active_ingredients": [{"name": "BERAHYALURONIDASE ALFA", "strength": "2000 U/mL"}, {"name": "PEMBROLIZUMAB", "strength": "165 mg/mL"}], "application_number": "BLA761467", "marketing_category": "BLA", "marketing_start_date": "20250919", "listing_expiration_date": "20271231"}