YONDELIS (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 1 Vial Carton

NDC 59676-610-01

Yondelis®
(trabectedin)

for Injection

1 mg per vial

For Intravenous Infusion Only

Reconstitute before further dilution

Each vial contains 1 mg of trabectedin as a
sterile lyophilized powder.

Rx only

Single-dose vialDiscard any unused portion

Cytotoxic

PRINCIPAL DISPLAY PANEL -- 1 Vial Carton
(click image for full-size original)
YONDELIS trabectedin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-610
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trabectedin (Trabectedin) Trabectedin 0.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sucrose
Potassium Phosphate, Monobasic
Phosphoric Acid
Potassium Hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-610-01 20 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207953 10/23/2015
Labeler — Janssen Products, LP (804684207)
Registrant — Janssen Pharmaceuticals, Inc. (063137772)
Establishment
Name Address ID/FEI Operations
Pharma Mar S.A. 464884501 API MANUFACTURE (59676-610)
Establishment
Name Address ID/FEI Operations
Baxter Oncology GmbH 344276063 MANUFACTURE (59676-610)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 370005019 MANUFACTURE (59676-610)

Revised: 09/2020 Janssen Products, LP

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