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NDC 43547-0311-09 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5; 80 mg/1; mg/1 Details
VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5; 80 mg/1; mg/1
VALSARTAN AND HYDROCHLOROTHIAZIDE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Solco Healthcare US, LLC. The primary component is HYDROCHLOROTHIAZIDE; VALSARTAN.
MedlinePlus Drug Summary
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: 43547-0311-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrochlorothiazide
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: 43547-0311-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Valsartan and Hydrochlorothiazide
Product Information
| NDC | 43547-0311 |
|---|---|
| Product ID | 43547-311_1b876e29-1212-4e28-8d3c-e2e717a8fe53 |
| Associated GPIs | 36994002700320 |
| GCN Sequence Number | 037354 |
| GCN Sequence Number Description | valsartan/hydrochlorothiazide TABLET 80-12.5MG ORAL |
| HIC3 | A4I |
| HIC3 Description | ANGIOTENSIN RECEPTOR ANTAG.-THIAZIDE DIURETIC COMB |
| GCN | 07833 |
| HICL Sequence Number | 017084 |
| HICL Sequence Number Description | VALSARTAN/HYDROCHLOROTHIAZIDE |
| Brand/Generic | Generic |
| Proprietary Name | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | valsartan and hydrochlorothiazide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 80 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | HYDROCHLOROTHIAZIDE; VALSARTAN |
| Labeler Name | Solco Healthcare US, LLC |
| Pharmaceutical Class | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206083 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43547-0311-09 (43547031109)
| NDC Package Code | 43547-311-09 |
|---|---|
| Billing NDC | 43547031109 |
| Package | 90 TABLET, FILM COATED in 1 BOTTLE (43547-311-09) |
| Marketing Start Date | 2021-12-03 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.16105 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | VALSARTAN-HYDROCHLOROTHIAZIDE 80-12.5 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |