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NDC 00574-1133-04 SPIRONOLACTONE 25 mg/5mL Details
SPIRONOLACTONE 25 mg/5mL
SPIRONOLACTONE is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis US LLC. 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: 00574-1133-04Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Spironolactone
Product Information
| NDC | 00574-1133 |
|---|---|
| Product ID | 0574-1133_522bd365-ddcc-48f4-8a98-66dc4c3bb314 |
| Associated GPIs | |
| GCN Sequence Number | 046605 |
| GCN Sequence Number Description | spironolactone ORAL SUSP 25 MG/5 ML ORAL |
| HIC3 | R1H |
| HIC3 Description | POTASSIUM SPARING DIURETICS |
| GCN | 15596 |
| 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 | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/5mL |
| Substance Name | SPIRONOLACTONE |
| Labeler Name | Padagis US LLC |
| Pharmaceutical Class | Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA209478 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00574-1133-04 (00574113304)
| NDC Package Code | 0574-1133-04 |
|---|---|
| Billing NDC | 00574113304 |
| Package | 118 mL in 1 BOTTLE (0574-1133-04) |
| Marketing Start Date | 2023-10-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |