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NDC 00054-0255-13 Irbesartan and Hydrochlorothiazide 12.5; 300 mg/1; mg/1 Details
Irbesartan and Hydrochlorothiazide 12.5; 300 mg/1; mg/1
Irbesartan and Hydrochlorothiazide is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is HYDROCHLOROTHIAZIDE; IRBESARTAN.
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: 00054-0255-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrochlorothiazide
Irbesartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat kidney disease caused by diabetes in patients with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) and high blood pressure. Irbesartan 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 it 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: 00054-0255-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Irbesartan
Product Information
| NDC | 00054-0255 |
|---|---|
| Product ID | 0054-0255_1786e07d-ad22-4e8b-b999-3442da68882e |
| Associated GPIs | 36994002300340 |
| GCN Sequence Number | 041897 |
| GCN Sequence Number Description | irbesartan/hydrochlorothiazide TABLET 300-12.5MG ORAL |
| HIC3 | A4I |
| HIC3 Description | ANGIOTENSIN RECEPTOR ANTAG.-THIAZIDE DIURETIC COMB |
| GCN | 11295 |
| HICL Sequence Number | 018963 |
| HICL Sequence Number Description | IRBESARTAN/HYDROCHLOROTHIAZIDE |
| Brand/Generic | Generic |
| Proprietary Name | Irbesartan and Hydrochlorothiazide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Irbesartan and Hydrochlorothiazide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 300 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | HYDROCHLOROTHIAZIDE; IRBESARTAN |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| 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 | ANDA090351 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-0255-13 (00054025513)
| NDC Package Code | 0054-0255-13 |
|---|---|
| Billing NDC | 00054025513 |
| Package | 30 TABLET in 1 BOTTLE (0054-0255-13) |
| Marketing Start Date | 2012-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.2191 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | IRBESARTAN-HYDROCHLOROTHIAZIDE 300-12.5 MG TB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |