Palonosetron Hydrochloride (Page 6 of 6)

Package/Label Display Panel

Palonosetron HCl Injection 0.05 mg/mL, 5 mL Single-Use Vial Carton Text

NDC 0703-4094 -01 Rx only

Palonosetron

HCl Injection

0.25 mg/5 mL

(0.05 mg/mL)

For Intravenous Injection Only.

5 mL Single-Dose Sterile Vial.

Discard unused portion.

TEVA

PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-4094 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PALONOSETRON HYDROCHLORIDE (PALONOSETRON) PALONOSETRON 0.25 mg in 5 mL

Inactive Ingredients Ingredient Name Strength MANNITOL EDETATE DISODIUM TRISODIUM CITRATE DIHYDRATE CITRIC ACID MONOHYDRATE WATER HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0703-4094-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 1 5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0703-4094-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090713 03/23/2018

Labeler — Teva Parenteral Medicines, Inc. (794362533)

Revised: 01/2020 Teva Parenteral Medicines, Inc.