Spironolactone
- Product NDC
- 50090-6458
- 11-digit product format
- 500906458
- Labeler code
- 50090
- Product ID
- 50090-6458_17f7df99-eeea-4589-9c3e-5901a411447f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2021-01-04
- Substance
- SPIRONOLACTONE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 27O7W4T232 | SPIRONOLACTONE | 52-01-7 | SPIRONOLACTONE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6458-0 | 50090645800 | 100 TABLET, COATED in 1 BOTTLE (50090-6458-0) | 2023-05-01 | No | No | Historical |
| 50090-6458-1 | 50090645801 | 90 TABLET, COATED in 1 BOTTLE (50090-6458-1) | 2023-05-01 | No | No | Historical |
| 50090-6458-2 | 50090645802 | 30 TABLET, COATED in 1 BOTTLE (50090-6458-2) | 2023-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Spironolactone | A-S Medication Solutions | 2025-12-02 | HUMAN PRESCRIPTION DRUG LABEL | 5 |