ABELCET: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED

Single-use vials along with 5-micron filter needles are individually packaged.

100 mg of ABELCET ^® in 20 mL of suspension NDC 57665-101-41

Storage

Prior to admixture, ABELCET ^® should be stored at 2° to 8°C (36° to 46°F) and protected from exposure to light. Do not freeze. ABELCET ^® should be retained in the carton until time of use.

The admixed ABELCET ^® and 5% Dextrose Injection may be stored for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded.

U.S. Patent Nos. 4,973,465

5,616,334

6,406,713

I-101-41-US-Q

Manufactured by Exelead, Inc., Indianapolis, IN 46268

Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878

Revised 11/2018

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 57665-101-41

100 mg

ABELCET®
(Amphotericin B Lipid Complex Injection)

Lipid
Formulation

For Intravenous Use Only

5 mg/mL

Contents:
One 100 mg vial
One filter needle

Manufactured by:
Exelead, Inc.
Indianapolis, IN 46268

Distributed by: Leadiant
Biosciences, Inc.
Gaithersburg, MD 20878

U.S. PATENT NOS. 4,973,465 5,616,334 6,406,713

C-101-41-US-M

NDC 57665-101-41

100 mg

ABELCET®
(Amphotericin B Lipid Complex Injection)

For Intravenous Use Only

Each mL of ABELCET contains:
Amphotericin B USP 5 mg
L-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg
L-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg
Sodium Chloride USP 9 mg
Water for Injection USP, q.s. 1 mL

Preparation
ABELCET must be added to 5% Dextrose Injection USP
before intravenous infusion.
See package insert for complete directions.

Dosage
See package insert for dosage and administration information.

Storage
Store between 2° and 8°C (36° to 46°F). Do not freeze. Protect from light. Single-use vial.

Rx Only.

ABELCET amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57665-101 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPHOTERICIN B (AMPHOTERICIN B) AMPHOTERICIN B 5 mg in 1 mL DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- (DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-) DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- 3.4 mg in 1 mL DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- (DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- 1.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57665-101-41 1 VIAL in 1 CARTON contains a VIAL 1 20 mL in 1 VIAL This package is contained within the CARTON (57665-101-41)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050724 10/18/2010

Labeler — Leadiant Biosciences, Inc. (068301431)

Revised: 12/2022 Leadiant Biosciences, Inc.