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Drug Information

Product NDC: 0006-3026

Proprietary Name: KEYTRUDA

Non Proprietary Name: pembrolizumab

Active Ingredient(s):

Administration Route(s): INTRAVENOUS


Pharmacy Class(es):
  • Programmed Death Receptor-1 Blocking Antibody [EPC];
  • Programmed Death Receptor-1-directed Antibody Interactions [MoA]

Labeler Information

Labeler Name: Merck Sharp & Dohme LLC
FDA Application Number: BLA125514
Marketing Category: BLA
Start Marketing Date:1/15/2015

Package Information

No. Package Code Package Description Billing Unit
10006-3026-021 VIAL in 1 CARTON (0006-3026-02) / 10 mL in 1 VIAL (0006-3026-01)ML
20006-3026-042 VIAL in 1 CARTON (0006-3026-04) / 10 mL in 1 VIAL (0006-3026-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-3026The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEKEYTRUDAThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEpembrolizumabThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/15/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at under Structured Product Labeling Resources.
APPLICATION NUMBERBLA125514This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMerck Sharp & Dohme LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPEMBROLIZUMABAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESProgrammed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA] 

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This page was last updated on: 2/1/2023