NDC Code(s) : 0143-9875-01, 0143-9875-10, 0143-9875-25
Packager : Hikma Pharmaceuticals USA 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:0143-9875
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
POLYSORBATE 80(UNII: 6OZP39ZG8H)100 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)20.2 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9875-1010 in 1 BOX 25/02/2008
1NDC:0143-9875-013 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:0143-9875-2525 in 1 BOX 25/02/2008
2NDC:0143-9875-013 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 ANDA077234 02/25/2008

LABELER - Hikma Pharmaceuticals USA Inc.(001230762)

Establishment
Name Address ID/FEI Business Operations
HIKMA FARMACEUTICA (PORTUGAL), S.A 452742943 manufacture(0143-9875)

PRINCIPAL DISPLAY PANEL

NDC 0143-9875-01       Rx only

Amiodarone Hydrochloride Injection, USP

150mg per 3 mL

(50 mg/mL)

For Intravenous use ONLY

3mL Single Dose Vial

amiodarone vial

PRINCIPAL DISPLAY PANEL

NDC 0143-9875-25       Rx only

Amiodarone Hydrochloride Injection, USP

150mg per 3 mL

(50 mg/mL)

For Intravenous use ONLY

25 x 3mL Single Dose Vials

amiodarone shelfpack

NDC 0143-9875-10      Rx only

Amiodarone Hydrochloride Injection, USP

150mg per 3 mL

(50 mg/mL)

For Intravenous use ONLY

10 x 3mL Single Dose Vials

amiodarone shelfpack