Benicar Hct (Page 4 of 4)

HOW SUPPLIED

BENICAR HCT ® is supplied as 20 mg/12.5 mg: reddish-yellow, circular, film-coated tablets, approximately 8.5 mm in diameter, with “Sankyo” debossed on one side and “C22” on the other side. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

40 mg/12.5 mg: reddish-yellow, oval, film-coated tablets, approximately 15 x 7 mm, with “Sankyo” debossed on one side and “C23” on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

40 mg/25 mg: pink, oval, film-coated tablets, approximately 15 x 7 mm, with “Sankyo” debossed on one side and “C25” on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

Tablets are supplied as follows:

20 mg/12.5 mg40 mg/12.5 mg40 mg/25 mg
Bottle of 30 tabletsNDC 54868-5170-0NDC 54868-5075-0NDC 54868-5078-0
Bottle of 90 tabletsNDC 54868-5170-1NDC 54868-5075-1NDC 54868-5078-1

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].

Manufactured for Daiichi Sankyo, Inc., Parsippany, NJ 07054

Rx Only

Copyright © Daiichi Sankyo, Inc. 2006. All rights reserved.

P1800706 Rev. December 2006

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

BENICAR HCT ®

20 mg/12.5 mg

image of 20/12.5 mg package label
(click image for full-size original)

40 mg/12.5 mg

image of 40/12.5 mg package label
(click image for full-size original)

40 mg/25 mg

image of 40/25 mg package label
(click image for full-size original)

BENICAR HCT olmesartan medoxomil and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5170(NDC:65597-105)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
LACTOSE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow (reddish-yellow) Score no score
Shape ROUND (round) Size 9mm
Flavor Imprint Code Sankyo;C22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5170-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5170-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021532 10/15/2004
BENICAR HCT olmesartan medoxomil and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5075(NDC:65597-106)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
LACTOSE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow (reddish-yellow) Score no score
Shape OVAL (oval) Size 15mm
Flavor Imprint Code Sankyo;C23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5075-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5075-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021532 06/01/2004
BENICAR HCT olmesartan medoxomil and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5078(NDC:65597-107)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
LACTOSE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color pink (pink) Score no score
Shape OVAL (oval) Size 15mm
Flavor Imprint Code Sankyo;C25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5078-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5078-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021532 06/02/2004
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 11/2010 Physicians Total Care, Inc.

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