p;
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 225 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
SHELLAC
SODIUM LAURYL SULFATE
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (Opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RELIANT;225
Contains
Packaging
Item Code Package Description
1 NDC:0173-0786-01 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021416 03/28/2008 03/28/2013
RYTHMOL SR
propafenone hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0788
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 325 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
SHELLAC
SODIUM LAURYL SULFATE
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (Opaque) , RED (single band) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code RELIANT;325
Contains
Packaging
Item Code Package Description
1 NDC:0173-0788-01 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021416 04/01/2008 05/03/2013
RYTHMOL SR
propafenone hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0789
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 425 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
SHELLAC
SODIUM LAURYL SULFATE
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (Opaque) , RED (3 bands) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code RELIANT;425
Contains
Packaging
Item Code Package Description
1 NDC:0173-0789-01 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021416 04/01/2008 05/03/2013
Labeler - GlaxoSmithKline LLC (167380711)
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