Palonosetron Hydrochloride (Page 7 of 7)

Package/Label Display Panel — – 0.25 mg/5 mL – Carton Label

NDC 36000-326-02 5 mL Single-dose sterile vial

Palonosetron Hydrochloride Injection

0.25 mg/5 mL
(0.05 mg*/mL)

For Intravenous Injection Only

Rx Only

Contents: *Each mL of aqueous solution contains palonosetron hydrochloride equivalent to 0.05 mg palonosetron. Each mL also contains 41.5 mg mannitol, 0.5 mg edetate disodium, 3.7 mg sodium citrate, 1.56 mg citric acid monohydrate and water for injection (q.s. to 1 mL). Hydrochloric acid or sodium hydroxide may have been added to adjust pH.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature].

Protect from freezing. Protect from light.

Discard unused portion.

See package insert for dosage and administration information.

Manufactured By:

Baxter Oncology GmbH

Kantstraβe 2

33790 Halle/Westfalen

Germany

Manufactured For:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

2021-09-15

PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-326 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 CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36000-326-02 1 VIAL in 1 CARTON contains a VIAL (36000-326-01) 1 NDC:36000-326-01 5 mL in 1 VIAL This package is contained within the CARTON (36000-326-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206916 11/12/2021

Labeler — Baxter Healthcare Corporation (005083209)

Registrant — Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Operations
Baxter Oncology GmbH		344276063	MANUFACTURE (36000-326), ANALYSIS (36000-326), LABEL (36000-326), PACK (36000-326), STERILIZE (36000-326)

Revised: 09/2020 Baxter Healthcare Corporation