Home NDC 0006-3026 KEYTRUDA
Product NDC 0006-3026
11-digit product format 000063026
Labeler code 0006
Product ID 0006-3026_2251fde0-831a-4f47-a325-0859f3a235e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pembrolizumab
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme LLC
Application BLA125514
Marketing category BLA
Marketing start 2015-01-15
Substance PEMBROLIZUMAB
Active strength 25 mg/mL
Pharmacologic classes 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMBROLIZUMAB 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DPT0O3T46P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1657746 Internal RxNorm lookup 1657749 Internal RxNorm lookup 1657750 Internal RxNorm lookup 1657751 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-3026-01 KEYTRUDA 4 mL in 1 VIAL INJECTION, SOLUTION 4 225 0006-3026-02 KEYTRUDA 1 in 1 CARTON INJECTION, SOLUTION 1 225 0006-3026-04 KEYTRUDA 2 in 1 CARTON INJECTION, SOLUTION 2 225
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded pembrolizumab ACTIVE INGREDIENT DPT0O3T46P KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9 pembrolizumab ACTIVE MOIETY DPT0O3T46P KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9 HISTIDINE INACTIVE INGREDIENT 4QD397987E KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9 SUCROSE INACTIVE INGREDIENT C151H8M554 KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9 WATER INACTIVE INGREDIENT 059QF0KO0R KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-3026 KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC ] 207 Current NDC, Legacy NDC, 3 package rows 20250430_9333c79b-d487-4538-a9f0-71b91a02b287.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125514 Keytruda pembrolizumab 351(a) Disc 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-3026-01 00006302601 4 mL in 1 VIAL 4 ml Historical 0006-3026-02 00006302602 1 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01) 1 vial 2015-01-15 0000-00-00 No No Current 0006-3026-04 00006302604 2 VIAL in 1 CARTON (0006-3026-04) / 4 mL in 1 VIAL (0006-3026-01) 2 vial 2019-08-01 0000-00-00 No No Current