Propafenone Hydrochloride (Page 7 of 7)

Package/Label Display Panel

Propafenone Hydrochloride Tablets USP, 150 mg
NDC 62559-230-01
Rx only
100 Tablets

150mg-label
(click image for full-size original)

Package/Label Display Panel

Propafenone Hydrochloride Tablets USP, 225 mg
NDC 62559-231-01
Rx only
100 Tablets

225mg-label
(click image for full-size original)

Package/Label Display Panel

Propafenone Hydrochloride Tablets USP, 300 mg
NDC 62559-232-01
Rx only
100 Tablets

300mg-label
(click image for full-size original)

PROPAFENONE HYDROCHLORIDE propafenone hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-230
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POVIDONE K30
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
MALTODEXTRIN
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code ANI;230
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-230-01 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076550 03/31/2015
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-231
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
STARCH, CORN
POVIDONE K30
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
MALTODEXTRIN
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code ANI;231
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-231-01 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076550 03/31/2015
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-232
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POVIDONE K30
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
MALTODEXTRIN
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code ANI;232
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-232-01 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076550 03/31/2015
Labeler — ANI Pharmaceuticals, Inc. (145588013)
Registrant — ANI Pharmaceuticals, Inc. (145588013)

Revised: 11/2018 ANI Pharmaceuticals, Inc.

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