Olmesartan Medoxomil and Hydrochlorothiazide (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Olmesartan medoxomil and hydrochlorothiazide tablets 20 mg/12.5 mg are reddish-yellow, round shaped, biconvex film-coated tablets, debossed with ‘K’ on one side and ‘23’ on the other side.
Bottles of 30 NDC 65862-779-30
Bottles of 90 NDC 65862-779-90
Bottles of 1,000 NDC 65862-779-99
10 x 10 Unit-dose Tablets NDC 65862-779-78
Olmesartan medoxomil and hydrochlorothiazide tablets 40 mg/12.5 mg are reddish-yellow, oval shaped, biconvex film-coated tablets, debossed with ‘K’ on one side and ‘53’ on the other side.
Bottles of 30 NDC 65862-780-30
Bottles of 90 NDC 65862-780-90
Bottles of 1,000 NDC 65862-780-99
10 x 10 Unit-dose Tablets NDC 65862-780-78
Olmesartan medoxomil and hydrochlorothiazide tablets 40 mg/25 mg are pink, oval shaped, biconvex film-coated tablets, debossed with ‘K’ on one side and ‘54’ on the other side.
Bottles of 30 NDC 65862-781-30
Bottles of 90 NDC 65862-781-90
Bottles of 1,000 NDC 65862-781-99
10 x 10 Unit-dose Tablets NDC 65862-781-78
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Use in Specific Populations (8.1)].

Symptomatic hypotension and syncope: Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure. If syncope occurs advise patients, to contact their healthcare provider.

Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.

Acute myopia and secondary angle-closure glaucoma : Advise patients to discontinue olmesartan medoxomil and hydrochlorothiazide and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.6)].

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 09/2020

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/12.5 mg (30 Tablets Bottle)

NDC 65862-779-30
Rx only
Olmesartan Medoxomil
and Hydrochlorothiazide
Tablets
20 mg/12.5 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg/12.5 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/12.5 mg (30 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-779-78
Rx only
Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
20 mg/12.5 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg (30 Tablets Bottle)

NDC 65862-780-30
Rx only
Olmesartan Medoxomil
and Hydrochlorothiazide
Tablets
40 mg/12.5 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg/12.5 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-780-78
Rx only
Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
40 mg/12.5 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/25 mg (30 Tablets Bottle)

NDC 65862-781-30
Rx only
Olmesartan Medoxomil
and Hydrochlorothiazide
Tablets
40 mg/25 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg/25 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/25 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-781-78
Rx only
Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
40 mg/25 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg/25 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-779
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 (110000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Reddish-Yellow) Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code K;23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-779-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-779-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-779-99 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-779-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-779-10)
4 NDC:65862-779-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-779-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205391 04/24/2017
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-780
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 (110000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Reddish-Yellow) Score no score
Shape OVAL (Biconvex) Size 15mm
Flavor Imprint Code K;53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-780-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-780-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-780-99 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-780-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-780-10)
4 NDC:65862-780-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-780-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205391 04/24/2017
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-781
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 (110000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape OVAL (Biconvex) Size 15mm
Flavor Imprint Code K;54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-781-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-781-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-781-99 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-781-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-781-10)
4 NDC:65862-781-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-781-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205391 04/24/2017
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-779), ANALYSIS (65862-780), ANALYSIS (65862-781), MANUFACTURE (65862-779), MANUFACTURE (65862-780), MANUFACTURE (65862-781)

Revised: 09/2020 Aurobindo Pharma 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 © 2024. All Rights Reserved.