AMIODARONE HCI (Page 5 of 5)

HOW SUPPLIED

AMIODARONE HCI INJECTION is supplied in the following dosage forms.
NDC 51662-1363-1
AMIODARONE HCI INJECTION 150 mg/3 mL (50 mg/mL) 3 mL VIAL

HF Acquisition Co LLC, DBA HealthFirst
Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

Amiodarone HCl Injection is supplied as:

HOW SUPPLIED
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Vial stoppers do not contain natural rubber latex.

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

Protect from light and excessive heat.

Use carton to protect contents from light until used.

SPL UNCLASSIFIED

LOGO
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45887H

Revised: April 2008

PRINCIPAL DISPLAY PANEL — VIAL LABEL

VIAL
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PRINCIPAL DISPLAY PANEL — SERIALIZED LABELING

SERIALIZED LABELING
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AMIODARONE HCI
amiodarone hci injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1363(NDC:63323-616)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 20.2 mg in 1 mL
POLYSORBATE 80 100 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1363-1 3 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075761 12/08/2019
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1363)

Revised: 02/2020 HF Acquisition Co LLC, DBA HealthFirst

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