Cardura XL (Page 6 of 6)

PRINCIPAL DISPLAY PANEL – 4 mg

NDC 58151-078-93

Cardura® XL
(doxazosin)
extended-release tablets
4 mg*

30 Tablets Rx only

Store at 25ºC (77ºF);
excursions permitted to
15-30ºC (59-86ºF)
[see USP Controlled Room
Temperature].

PROTECT FROM MOISTURE
AND HUMIDITY.

DOSAGE AND USE
See accompanying
prescribing information.

*Each tablet contains 5.1 mg
doxazosin mesylate which
includes an overage to provide
4 mg doxazosin as a free base.

Distributed by:
Viatris Specialty LLC Morgantown, WV 26505 U.S.A.

© 2023 Viatris Inc.

RUPJ078H

Cardura XL Extended Release Tablets 4 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 8 mg

NDC 58151-079-93

Cardura® XL
(doxazosin)
extended-release tablets
8 mg*

30 Tablets Rx only

Store at 25ºC (77ºF);
excursions permitted to
15-30ºC (59-86ºF)
[see USP Controlled Room
Temperature].

PROTECT FROM MOISTURE
AND HUMIDITY.

DOSAGE AND USE
See accompanying
prescribing information.

*Each tablet contains 10.2 mg
doxazosin mesylate which
includes an overage to provide
8 mg doxazosin as a free base.

Distributed by:
Viatris Specialty LLC Morgantown, WV 26505 U.S.A.

© 2023 Viatris Inc.

RUPJ079H

Cardura XL Extended Release Tablets 8 mg Bottle Label
(click image for full-size original)
CARDURA XL doxazosin mesylate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58151-078
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXAZOSIN MESYLATE (DOXAZOSIN) DOXAZOSIN 4 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
CELLULOSE ACETATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
SHELLAC
FERRIC OXIDE RED
SODIUM CHLORIDE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code CXL;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58151-078-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021269 01/04/2024
CARDURA XL doxazosin mesylate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58151-079
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXAZOSIN MESYLATE (DOXAZOSIN) DOXAZOSIN 8 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
CELLULOSE ACETATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
SHELLAC
FERRIC OXIDE RED
SODIUM CHLORIDE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code CXL;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58151-079-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021269 01/04/2024
Labeler — Viatris Specialty LLC (117455616)

Revised: 05/2023 Viatris Specialty LLC

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