FDA.reportPublic FDA data

KEYTRUDA

Product NDC
0006-3029
11-digit product format
000063029
Labeler code
0006
Product ID
0006-3029_dc05a1ee-eea1-4f08-b201-a8e6f97cde13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pembrolizumab
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme Corp.
Application
BLA125514
Marketing category
BLA
Marketing start
2014-09-04
Marketing end
0000-00-00
Substance
PEMBROLIZUMAB
Active strength
50 mg/2mL
Pharmacologic classes
Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0006-3029DDiscontinued by firm2026-07-31
excluded packagepackage0006-30290006-3029-02DDiscontinued by firm2026-07-31

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KEYTRUDAPEMBROLIZUMABMerck Sharp & Dohme LLC9333c79b-d487-4538-a9f0-71b91a02b2872026-07-10Warnings, Adverse reactionsExact identifier
application number: BLA125514
ndc (product): 0006-3029

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8e8f9c11-8c94-4615-8579-57b2877ce51bProduct name120150325
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3029-01KEYTRUDA15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,15225
0006-3029-02KEYTRUDA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1225

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3029-01EA - Each0006-30298a43e600-eb72-4337-a644-fdcb28ca314e12014-10-03
0006-3029-02EA - Each0006-3029a8cd2bc6-e391-49eb-b881-522c38ec1b5412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pembrolizumabACTIVE INGREDIENTDPT0O3T46PKEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]9
pembrolizumabACTIVE MOIETYDPT0O3T46PKEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]9
HISTIDINEINACTIVE INGREDIENT4QD397987EKEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HKEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]9
SUCROSEINACTIVE INGREDIENTC151H8M554KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]9
WATERINACTIVE INGREDIENT059QF0KO0RKEYTRUDA (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
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3029KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC ]207Legacy NDC, 2 package rows20250430_9333c79b-d487-4538-a9f0-71b91a02b287.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125514Keytrudapembrolizumab351(a)Disc2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657751Keytruda 100 MG in 4 ML InjectionPSN9333c79b-d487-4538-a9f0-71b91a02b287225
1657749Keytruda 50 MG InjectionPSN9333c79b-d487-4538-a9f0-71b91a02b287225
1657750pembrolizumab 100 MG in 4 ML InjectionPSN9333c79b-d487-4538-a9f0-71b91a02b287225
1657746pembrolizumab 50 MG InjectionPSN9333c79b-d487-4538-a9f0-71b91a02b287225
16577514 ML pembrolizumab 25 MG/ML Injection [Keytruda]SBD9333c79b-d487-4538-a9f0-71b91a02b287225
1657749pembrolizumab 50 MG Injection [Keytruda]SBD9333c79b-d487-4538-a9f0-71b91a02b287225
16577504 ML pembrolizumab 25 MG/ML InjectionSCD9333c79b-d487-4538-a9f0-71b91a02b287225
1657746pembrolizumab 50 MG InjectionSCD9333c79b-d487-4538-a9f0-71b91a02b287225
1657751Keytruda 100 MG per 4 ML InjectionSY9333c79b-d487-4538-a9f0-71b91a02b287225
1657749Keytruda 50 MG InjectionSY9333c79b-d487-4538-a9f0-71b91a02b287225
1657750pembrolizumab 100 MG per 4 ML InjectionSY9333c79b-d487-4538-a9f0-71b91a02b287225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0006-3029-010000630290115 mL in 1 VIAL15 mlHistorical
0006-3029-02000063029021 in 1 CARTONHistorical