Foscarnet (Page 7 of 7)

HOW SUPPLIED

Foscarnet Sodium Injection, 24 mg per mL for intravenous infusion, is supplied in 250 mL glass bottles containing 6000 mg foscarnet sodium (24 mg per mL) as follows:

Product Code	Unit of Sale	Strength
875150	NDC 63323-875-50Individually packaged	6000 mg foscarnet sodium (24 mg per mL)

For Single Use Only.

Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].

Protect from excessive heat (above 40°C) and from freezing. If refrigerated or exposed to temperatures below the freezing point, precipitation may occur. By keeping the bottle at room temperature with repeated shaking, the precipitate can be brought into solution again.

Foscarnet Sodium Injection should be used only if the bottle and seal are intact, a vacuum is present, and the solution is clear and colorless.

Manufactured for:

Lake Zurich, IL 60047

Made in Austria

For Product Inquiry:
1-800-551-7176 or www.fresenius-kabi.com/us

451664A/Revised: May 2021

PACKAGE LABEL — PRINCIPAL DISPLAY — FOSCARNET 250 ML BOTTLE LABEL

NDC 63323-875-50 875150

Foscarnet Sodium
Injection
6,000 mg/250 mL
(24 mg/mL)

For Central Intravenous Infusion Only
Must Be Diluted for Peripheral Intravenous Infusion

For Single Use Only. Discard unused portion.Rx Only

PACKAGE LABEL — PRINCIPAL DISPLAY — FOSCARNET 250 ML CARTON PANEL

NDC 63323-875-50 875150

Foscarnet Sodium
Injection
6,000 mg/250 mL
(24 mg/mL)

For Central Intravenous Infusion Only
Must Be Diluted for Peripheral
Intravenous Infusion

For Single Use Only.
Discard unused portion.Rx Only

FOSCARNET foscarnet sodium injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-875 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength foscarnet sodium (foscarnet) foscarnet sodium 24 mg in 1 mL

Inactive Ingredients Ingredient Name Strength hydrochloric acid water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63323-875-50 1 BOTTLE in 1 CARTON contains a BOTTLE 1 250 mL in 1 BOTTLE This package is contained within the CARTON (63323-875-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212483 01/29/2021

Labeler — Fresenius Kabi USA, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
Fresenius Kabi Austria		300206604	ANALYSIS (63323-875), MANUFACTURE (63323-875), PACK (63323-875)

Revised: 06/2021 Fresenius Kabi USA, LLC