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NDC 65862-0835-30 Amlodipine, Valsartan and Hydrochlorothiazide 5; 25; 160 mg/1; mg/1; mg/1 Details
Amlodipine, Valsartan and Hydrochlorothiazide 5; 25; 160 mg/1; mg/1; mg/1
Amlodipine, Valsartan and Hydrochlorothiazide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN.
MedlinePlus Drug Summary
Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. It is also used to treat certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 65862-0835-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Amlodipine
Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 65862-0835-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrochlorothiazide
Valsartan is used in adults and in children 1 year of age and older alone or in combination with other medications to treat high blood pressure. It is also used in adults to treat heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 65862-0835-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Valsartan
Combination product This product contains two medications, valsartan and hydrochlorothiazide. Please see the individual monographs for information about each of the medications contained in this product.
Related Packages: 65862-0835-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Valsartan and Hydrochlorothiazide
Product Information
| NDC | 65862-0835 |
|---|---|
| Product ID | 65862-835_2427a2ec-4baf-41c6-a39a-070bf61083e2 |
| Associated GPIs | 36994503200325 |
| GCN Sequence Number | 065150 |
| GCN Sequence Number Description | amlodipine/valsartan/hcthiazid TABLET 5-160-25MG ORAL |
| HIC3 | A4V |
| HIC3 Description | ANGIOTEN.RECEPTR ANTAG-CALCIUM CHANL BLKR-THIAZIDE |
| GCN | 22648 |
| HICL Sequence Number | 036305 |
| HICL Sequence Number Description | AMLODIPINE BESYLATE/VALSARTAN/HYDROCHLOROTHIAZIDE |
| Brand/Generic | Generic |
| Proprietary Name | Amlodipine, Valsartan and Hydrochlorothiazide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Amlodipine, Valsartan and Hydrochlorothiazide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5; 25; 160 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], In |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206180 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0835-30 (65862083530)
| NDC Package Code | 65862-835-30 |
|---|---|
| Billing NDC | 65862083530 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (65862-835-30) |
| Marketing Start Date | 2017-12-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.26788 |
| Pricing Unit | EA |
| Effective Date | 2021-01-20 |
| NDC Description | AMLODIPINE-VALSARTAN-HYDROCHLOROTHIAZIDE 5-160-25 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2022-01-12 |