Amiodarone HCl (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC42494-307-03
Amiodarone Hydrochloride
Tablets
100 mg
30 Tablets Rx Only

(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC42494-308-06
Amiodarone Hydrochloride
Tablets
200 mg
60 Tablets Rx Only

(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC42494-309-03
Amiodarone Hydrochloride
Tablets
400 mg
30 Tablets Rx Only

(click image for full-size original)

AMIODARONE HCL amiodarone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42494-308 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 200 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE D&C YELLOW NO. 10 SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color yellow Score 2 pieces Shape ROUND (flat with beveled edges) Size 10mm Flavor Imprint Code AS;200 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42494-308-06 60 TABLET in 1 BOTTLE None

(click image for full-size original)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077069 01/01/2013

AMIODARONE HCL amiodarone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42494-309 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 400 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE D&C YELLOW NO. 10 SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color yellow Score 2 pieces Shape OVAL (oval, biconvex) Size 16mm Flavor Imprint Code AS;400 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42494-309-03 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077069 01/01/2013

AMIODARONE HCL amiodarone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42494-307 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE D&C YELLOW NO. 10 SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code AS;100 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42494-307-03 30 TABLET in 1 BOTTLE None

(click image for full-size original)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077069 01/01/2017

Revised: 12/2022 Cameron Pharmaceuticals, LLC