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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0006-3029		D	Discontinued by firm		2026-08-17
excluded package	package	0006-3029	0006-3029-02	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0006-3029-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0006-3029-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0006-3029-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0006-3029-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0006-3029-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0006-3029-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0006-3029-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0006-3029-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0006-3029-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0006-3029-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0006-3029-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0006-3029-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8e8f9c11-8c94-4615-8579-57b2877ce51b	Product name	1	20150325
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-3029-01	KEYTRUDA	15 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	15		225
0006-3029-02	KEYTRUDA	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		225

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-3029-01	EA - Each	0006-3029	8a43e600-eb72-4337-a644-fdcb28ca314e	1	2014-10-03
0006-3029-02	EA - Each	0006-3029	a8cd2bc6-e391-49eb-b881-522c38ec1b54	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
0006-3029	KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC ]	207	Legacy NDC, 2 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KEYTRUDA	PEMBROLIZUMAB	Merck Sharp & Dohme LLC	9333c79b-d487-4538-a9f0-71b91a02b287	2026-07-10	Warnings, Adverse reactions	Exact identifier application number: BLA125514 ndc (product): 0006-3029

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DPT0O3T46P	PEMBROLIZUMAB	1374853-91-4	PEMBROLIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1657751	Keytruda 100 MG in 4 ML Injection	PSN	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657749	Keytruda 50 MG Injection	PSN	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657750	pembrolizumab 100 MG in 4 ML Injection	PSN	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657746	pembrolizumab 50 MG Injection	PSN	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657751	4 ML pembrolizumab 25 MG/ML Injection [Keytruda]	SBD	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657749	pembrolizumab 50 MG Injection [Keytruda]	SBD	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657750	4 ML pembrolizumab 25 MG/ML Injection	SCD	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657746	pembrolizumab 50 MG Injection	SCD	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657751	Keytruda 100 MG per 4 ML Injection	SY	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657749	Keytruda 50 MG Injection	SY	9333c79b-d487-4538-a9f0-71b91a02b287	225
1657750	pembrolizumab 100 MG per 4 ML Injection	SY	9333c79b-d487-4538-a9f0-71b91a02b287	225

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0006-3029-01	00006302901	15 mL in 1 VIAL	15 ml	Historical
0006-3029-02	00006302902	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KEYTRUDA	Merck Sharp & Dohme LLC \| MSD International Business GmbH	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	228