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

carton
(click image for full-size original)
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

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