NDC Code(s) : 0409-1934-11, 0409-1934-01, 0409-1933-02, 0409-1933-03
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1934
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE(UNII: 976728SY6Z)
(AMIODARONE - UNII:N3RQ532IUT) 		AMIODARONE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1934-0110 in 1 CARTON 25/11/2013
1NDC:0409-1934-113 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203884 11/25/2013 11/25/2013
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1933
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE(UNII: 976728SY6Z)
(AMIODARONE - UNII:N3RQ532IUT) 		AMIODARONE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1933-021 in 1 CARTON 25/11/2013
19 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:0409-1933-031 in 1 CARTON 25/11/2013
218 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203885 11/25/2013 11/25/2013

PRINCIPAL DISPLAY PANEL

AMIODARONE
HCl INJECTION

150 mg/3 mL
(50 mg/mL)

FOR INTRAVENOUS USE ONLY
Sterile
MUST BE DILUTED

Rx only
Hospira

PRINCIPAL DISPLAY PANEL - 150 mg/3 mL Vial Labels

PRINCIPAL DISPLAY PANEL

NDC 0409-1934-01
10 x 3 mL Single Use Vials

AMIODARONE HYDROCHLORIDE INJECTION

150 mg/3 mL
(50 mg/mL)

FOR INTRAVENOUS USE ONLY
Sterile

MUST BE DILUTED

Rx only
Hospira

PRINCIPAL DISPLAY PANEL - 150 mg/3 mL Vial Carton

PRINCIPAL DISPLAY PANEL

AMIODARONE
HCl INJECTION

450 mg/9 mL
(50 mg/mL)

FOR INTRAVENOUS USE ONLY
Sterile
MUST BE DILUTED

Rx only
Hospira

PRINCIPAL DISPLAY PANEL - 450 mg/9 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1933-02
9 mL Multiple Use Vial

AMIODARONE
HCl INJECTION

450 mg/9 mL
(50 mg/mL)

FOR INTRAVENOUS USE ONLY

Sterile

MUST BE DILUTED

Rx only
Hospira

PRINCIPAL DISPLAY PANEL - 450 mg/9 mL Vial Carton

PRINCIPAL DISPLAY PANEL

AMIODARONE
HCl INJECTION

900 mg/18 mL
(50 mg/mL)

FOR INTRAVENOUS USE ONLY
Sterile
MUST BE DILUTED

Rx only
Hospira

PRINCIPAL DISPLAY PANEL - 900 mg/18 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1933-03
18 mL Multiple Use Vial

AMIODARONE
HCl INJECTION

900 mg/18 mL
(50 mg/mL)

FOR INTRAVENOUS USE ONLY

Sterile

MUST BE DILUTED

Rx only
Hospira

PRINCIPAL DISPLAY PANEL - 900 mg/18 mL Vial Carton