Propafenone Hydrochloride (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 225 mg

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PRINCIPAL DISPLAY PANEL — 325 mg

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PRINCIPAL DISPLAY PANEL — 425 mg

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PROPAFENONE HYDROCHLORIDE
propafenone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-477(NDC:24979-085)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 225 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERRIC OXIDE RED
Product Characteristics
Color red (red opaque) , white (white opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TWi;T085;225
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-477-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212928 06/18/2020
PROPAFENONE HYDROCHLORIDE
propafenone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-478(NDC:24979-086)
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
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERRIC OXIDE RED
Product Characteristics
Color red (red opaque) , white (white opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code TWi;T086;325
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-478-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212928 06/18/2020
PROPAFENONE HYDROCHLORIDE
propafenone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-479(NDC:24979-087)
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
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERRIC OXIDE RED
Product Characteristics
Color red (red opaque) , white (white opaque) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code TWi;T087;425
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-479-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212928 06/18/2020
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-477), repack (51407-477), relabel (51407-478), repack (51407-478), relabel (51407-479), repack (51407-479)

Revised: 01/2024 Golden State Medical Supply, Inc.

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