Propafenone Hydrochloride (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PROPAFENONE HYDROCHLORIDE propafenone hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-825
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color WHITE (opaque white cap) , WHITE (opaque white body) Score no score
Shape CAPSULE (hard gelatin) Size 22mm
Flavor Imprint Code 408;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-825-01 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205268 03/31/2017
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-826
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color WHITE (opaque white cap) , WHITE (opaque white body) Score no score
Shape CAPSULE (hard gelatin) Size 23mm
Flavor Imprint Code 409;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-826-01 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205268 03/31/2017
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-827
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color WHITE (opaque white cap with black band) , WHITE (opaque white body with black band) Score no score
Shape CAPSULE (hard gelatin) Size 23mm
Flavor Imprint Code 410;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-827-01 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205268 03/31/2017
Labeler — Northstar Rx LLC (830546433)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS (16714-825), ANALYSIS (16714-826), ANALYSIS (16714-827), MANUFACTURE (16714-825), MANUFACTURE (16714-826), MANUFACTURE (16714-827)

Revised: 04/2019 Northstar Rx LLC

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