Edarbyclor (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg Tablet Bottle Label

NDC 60631-412-30
Rx Only

edarbyclor
Azilsartan Medoxomil and
Chlorthalidone Tablets

40 mg*/12.5 mg

*Each tablet contains: 42.68 mg azilsartan kamedoxomil
(equivalent to 40 mg azilsartan medoxomil) and 12.5 mg chlorthalidone.

Usual Dosage: See package insert.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
[See USP Controlled Room Temperature.]

30 Tablets
Do not accept if tamper-evident
ring is broken or missing.
Keep container tightly closed.
Protect from moisture and light.

Dispense
and store
in original
container.

Manufactured for:
arbor™
PHARMACEUTICALS, LLC.
Atlanta, GA 30328

Manufactured by:
Takeda
Osaka, Japan

L127-02EC-TL12-30-01

PRINCIPAL DISPLAY PANEL -- 40 mg/12.5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg/25 mg Tablet Bottle Label

NDC 60631-425-30
Rx Only

edarbyclor
Azilsartan Medoxomil and
Chlorthalidone Tablets

40 mg*/25 mg

*Each tablet contains: 42.68 mg azilsartan kamedoxomil
(equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone.

Usual Dosage: See package insert.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
[See USP Controlled Room Temperature.]

30 Tablets
Do not accept if tamper-evident
ring is broken or missing.
Keep container tightly closed.
Protect from moisture and light.

Dispense
and store
in original
container.

Manufactured for:
arbor™
PHARMACEUTICALS, LLC.
Atlanta, GA 30328

Manufactured by:
Takeda
Osaka, Japan

L129-02EC-TL25-30-01

PRINCIPAL DISPLAY PANEL -- 40 mg/25 mg Tablet Bottle Label
(click image for full-size original)
EDARBYCLOR azilsartan kamedoxomil and chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60631-412
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan kamedoxomil (AZILSARTAN) AZILSARTAN MEDOXOMIL 40 mg
chlorthalidone (chlorthalidone) chlorthalidone 12.5 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
CELLULOSE, MICROCRYSTALLINE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
polyethylene glycol 8000
BUTYL ALCOHOL
CROSPOVIDONE
water
FUMARIC ACID
SODIUM HYDROXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
HYPROMELLOSES
SHELLAC
FERROSOFERRIC OXIDE
ALCOHOL
Product Characteristics
Color RED (pale red) Score no score
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code AC;40;12;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60631-412-07 5 BLISTER PACK in 1 TRAY contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the TRAY (60631-412-07)
2 NDC:60631-412-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202331 02/01/2013
EDARBYCLOR azilsartan kamedoxomil and chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60631-425
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan kamedoxomil (AZILSARTAN) AZILSARTAN MEDOXOMIL 40 mg
chlorthalidone (chlorthalidone) chlorthalidone 25 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
CELLULOSE, MICROCRYSTALLINE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
polyethylene glycol 8000
BUTYL ALCOHOL
CROSPOVIDONE
water
FUMARIC ACID
SODIUM HYDROXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
HYPROMELLOSES
SHELLAC
FERROSOFERRIC OXIDE
ALCOHOL
Product Characteristics
Color RED (light red) Score no score
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code AC;40;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60631-425-07 5 BLISTER PACK in 1 TRAY contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the TRAY (60631-425-07)
2 NDC:60631-425-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202331 02/01/2013
Labeler — Arbor Pharmaceuticals Ireland Limited (985060592)

Revised: 08/2015 Arbor Pharmaceuticals Ireland Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.