NDC Code(s) : 51407-477-60, 51407-478-60, 51407-479-60
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Propafenone Hydrochloridepropafenone 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(UNII: 33XCH0HOCD)
(PROPAFENONE - UNII:68IQX3T69U) 		PROPAFENONE HYDROCHLORIDE225 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color red (red opaque), white (white opaque) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code TWi;T085;225
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-477-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212928 06/18/2020
Propafenone Hydrochloridepropafenone 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(UNII: 33XCH0HOCD)
(PROPAFENONE - UNII:68IQX3T69U) 		PROPAFENONE HYDROCHLORIDE325 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color red (red opaque), white (white opaque) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code TWi;T086;325
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-478-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212928 06/18/2020
Propafenone Hydrochloridepropafenone 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(UNII: 33XCH0HOCD)
(PROPAFENONE - UNII:68IQX3T69U) 		PROPAFENONE HYDROCHLORIDE425 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color red (red opaque), white (white opaque) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code TWi;T087;425
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-479-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/09/2021
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 Business Operations
Golden State Medical Supply, Inc. 603184490 repack(51407-477, 51407-478, 51407-479), relabel(51407-478, 51407-477, 51407-479)

PRINCIPAL DISPLAY PANEL

51407-477-60OL.jpg

PRINCIPAL DISPLAY PANEL

51407-478-60OL.jpg

PRINCIPAL DISPLAY PANEL

51407-479-60OL.jpg