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NDC 43063-0835-90 Spironolactone 100 mg/1 Details
Spironolactone 100 mg/1
Spironolactone is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is SPIRONOLACTONE.
MedlinePlus Drug Summary
Spironolactone is used to treat certain patients with hyperaldosteronism (the body produces too much aldosterone, a naturally occurring hormone); low potassium levels; heart failure; and in patients with edema (fluid retention) caused by various conditions, including liver, or kidney disease. It is also used alone or with other medications to treat high blood pressure. Spironolactone is in a class of medications called aldosterone receptor antagonists. It causes the kidneys to eliminate unneeded water and sodium from the body into the urine but reduces the loss of potassium from the body. 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: 43063-0835-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Spironolactone
Product Information
| NDC | 43063-0835 |
|---|---|
| Product ID | 43063-835_ffd8ac02-2f34-fe55-e053-6394a90af454 |
| Associated GPIs | 37500020000315 |
| GCN Sequence Number | 006816 |
| GCN Sequence Number Description | spironolactone TABLET 100 MG ORAL |
| HIC3 | R1H |
| HIC3 Description | POTASSIUM SPARING DIURETICS |
| GCN | 27690 |
| HICL Sequence Number | 002901 |
| HICL Sequence Number Description | SPIRONOLACTONE |
| Brand/Generic | Generic |
| Proprietary Name | Spironolactone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | spironolactone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | SPIRONOLACTONE |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203512 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0835-90 (43063083590)
| NDC Package Code | 43063-835-90 |
|---|---|
| Billing NDC | 43063083590 |
| Package | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-90) |
| Marketing Start Date | 2018-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |