Bosentan (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2511-60

Bosentan Tablets

62.5 mg

PHARMACIST: Dispense with accompanying Medication Guide.

Actavis

60 Tablets

Rx Only

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2512-60

Bosentan Tablets

125 mg

PHARMACIST: Dispense with accompanying Medication Guide.

Actavis

60 Tablets

Rx Only

2
(click image for full-size original)

BOSENTAN bosentan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2511
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOSENTAN (BOSENTAN ANHYDROUS) BOSENTAN ANHYDROUS 62.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
ETHYLCELLULOSE (10 MPA.S)
GLYCERYL BEHENATE/EICOSADIOATE
HYPROMELLOSE 2910 (15 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K90
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color ORANGE (LIGHT) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WPI;62;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2511-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207110 06/19/2019
BOSENTAN bosentan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2512
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOSENTAN (BOSENTAN ANHYDROUS) BOSENTAN ANHYDROUS 125 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
ETHYLCELLULOSE (10 MPA.S)
GLYCERYL BEHENATE/EICOSADIOATE
HYPROMELLOSE 2910 (15 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K90
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color ORANGE (LIGHT) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code WPI;125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2512-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207110 06/19/2019
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 05/2019 Actavis Pharma, Inc.

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