keytruda

Generic: pembrolizumab

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

Drug Facts

Product Profile

Brand Name keytruda
Generic Name pembrolizumab
Labeler merck sharp & dohme llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pembrolizumab 25 mg/mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-3026
Product ID 0006-3026_2224626f-467c-4655-828d-3dfc97fe41ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125514
Listing Expiration 2027-12-31
Marketing Start 2015-01-15

Pharmacologic Class

Established (EPC)
programmed death receptor-1 blocking antibody [epc]
Mechanism of Action
programmed death receptor-1-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00063026
Hyphenated Format 0006-3026

Supplemental Identifiers

UNII
DPT0O3T46P
NUI
N0000191260 N0000191259

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 (source: ndc)
Generic Name pembrolizumab (source: ndc)
Application Number BLA125514 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01)
  • 2 VIAL in 1 CARTON (0006-3026-04) / 4 mL in 1 VIAL (0006-3026-01)
source: ndc

Packages (2)

0006-3026-02 1 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01) 0006-3026-04 2 VIAL in 1 CARTON (0006-3026-04) / 4 mL in 1 VIAL (0006-3026-01)

Ingredients (1)

pembrolizumab (25 mg/mL)

Linked Drug Pages (1)

KEYTRUDA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2224626f-467c-4655-828d-3dfc97fe41ac", "openfda": {"nui": ["N0000191260", "N0000191259"], "unii": ["DPT0O3T46P"], "spl_set_id": ["9333c79b-d487-4538-a9f0-71b91a02b287"], "pharm_class_epc": ["Programmed Death Receptor-1 Blocking Antibody [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 (0006-3026-02)  / 4 mL in 1 VIAL (0006-3026-01)", "package_ndc": "0006-3026-02", "marketing_start_date": "20150115"}, {"sample": false, "description": "2 VIAL in 1 CARTON (0006-3026-04)  / 4 mL in 1 VIAL (0006-3026-01)", "package_ndc": "0006-3026-04", "marketing_start_date": "20190801"}], "brand_name": "KEYTRUDA", "product_id": "0006-3026_2224626f-467c-4655-828d-3dfc97fe41ac", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Programmed Death Receptor-1 Blocking Antibody [EPC]", "Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "product_ndc": "0006-3026", "generic_name": "pembrolizumab", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KEYTRUDA", "active_ingredients": [{"name": "PEMBROLIZUMAB", "strength": "25 mg/mL"}], "application_number": "BLA125514", "marketing_category": "BLA", "marketing_start_date": "20150115", "listing_expiration_date": "20271231"}