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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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 2026-06-01
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