Package 0006-5083-01
Brand: keytruda qlex
Generic: pembrolizumab and berahyaluronidase alfa-pmphPackage Facts
Identity
Package NDC
0006-5083-01
Digits Only
0006508301
Product NDC
0006-5083
Description
1 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99)
Marketing
Marketing Status
Brand
keytruda qlex
Generic
pembrolizumab and berahyaluronidase alfa-pmph
Sample Package
No
Linked Drug Pages (1)
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"}