Isoproterenol Hydrochloride (Page 3 of 3)

HOW SUPPLIED

NDC Number	Container	Concentration	Fill	Quantity
68682-433-01	Ampul	0.2 mg/mL	1 mL	10 ampuls per carton
68682-433-05	Ampul	1 mg/5 mL (0.2 mg/mL)	5 mL	10 ampuls per carton

Protect from light. Keep in opaque container until used.

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

Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.

Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC

Bridgewater, NJ 08807 USA

© 2020 Bausch Health Companies Inc. or its affiliates

Revised: 09/2020

9745500

8021443

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68682-433-05

Rx only

Isoproterenol Hydrochloride

Injection, USP

1 mg/5 mL (0.2 mg/mL)

Sterile Injection

Intravenous, Subcutaneous,

Intramuscular or Intracardiac Use Only

5 mL ampule x 10 ampuls per carton

OCEANSIDE PHARMACEUTICALS

ISOPROTERENOL HYDROCHLORIDE isoproterenol hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-433 Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROTERENOL HYDROCHLORIDE (ISOPROTERENOL) ISOPROTERENOL HYDROCHLORIDE 0.2 mg in 1 mL

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68682-433-01 10 AMPULE in 1 CARTON contains a AMPULE 1 1 mL in 1 AMPULE This package is contained within the CARTON (68682-433-01) 2 NDC:68682-433-05 10 AMPULE in 1 CARTON contains a AMPULE 2 5 mL in 1 AMPULE This package is contained within the CARTON (68682-433-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA010515 11/20/2020

Labeler — Oceanside Pharmaceuticals (832011691)

Establishment
Name	Address	ID/FEI	Operations
Avara Liscate Pharmaceutical Services Spa		564165541	MANUFACTURE (68682-433)

Revised: 09/2020 Oceanside Pharmaceuticals