KEYTRUDA (Page 21 of 21)

PRINCIPAL DISPLAY PANEL — 50 mg Vial Carton

NDC 0006-3029-02

Keytruda ^®
(pembrolizumab)
for Injection

50 mg / vial

For Intravenous Infusion Only

Dispense the enclosed Medication Guide to each patient.

Sterile lyophilized powder must be reconstituted with Sterile Water for
Injection, USP. Reconstituted solution requires further dilution priorto administration.

Rx only

Single-dose vial. Discard unused portion.

PRINCIPAL DISPLAY PANEL — 100 mg/4 mL Vial Carton

NDC 0006-3026-02

Keytruda^®
(pembrolizumab)
Injection

100 mg/4 mL
(25 mg/mL)

For Intravenous Infusion Only

Dispense the enclosed Medication Guide to each patient.

Requires dilution prior to administration.

Rx only Single-dose vial. Discard unused portion.

KEYTRUDA pembrolizumab injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-3029 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pembrolizumab (pembrolizumab) pembrolizumab 50 mg in 2 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE 3.1 mg in 2 mL SUCROSE 140 mg in 2 mL POLYSORBATE 80 0.4 mg in 2 mL SODIUM HYDROXIDE HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0006-3029-02 1 VIAL in 1 CARTON contains a VIAL (0006-3029-01) 1 NDC:0006-3029-01 15 mL in 1 VIAL This package is contained within the CARTON (0006-3029-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125514 09/04/2014 12/21/2015

KEYTRUDA pembrolizumab injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-3026 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pembrolizumab (pembrolizumab) pembrolizumab 25 mg in 1 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE 1.55 mg in 1 mL SUCROSE 70 mg in 1 mL POLYSORBATE 80 0.2 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0006-3026-02 1 VIAL in 1 CARTON contains a VIAL (0006-3026-01) 1 NDC:0006-3026-01 10 mL in 1 VIAL This package is contained within the CARTON (0006-3026-02) 2 NDC:0006-3026-04 2 VIAL in 1 CARTON contains a VIAL (0006-3026-01) 2 NDC:0006-3026-01 10 mL in 1 VIAL This package is contained within the CARTON (0006-3026-04)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125514 01/15/2015

Labeler — Merck Sharp & Dohme LLC (118446553)

Revised: 01/2023 Merck Sharp & Dohme LLC