Spironolactone
- Product NDC
- 50090-6539
- 11-digit product format
- 500906539
- Labeler code
- 50090
- Product ID
- 50090-6539_76b5d6ad-0b7b-4781-b990-5ba036cf5a67
- 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
- 100 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 |
|---|
| 50090-6539-0 | 50090653900 | 90 TABLET, COATED in 1 BOTTLE (50090-6539-0) | 2023-06-29 | No | No | Historical |
| 50090-6539-1 | 50090653901 | 30 TABLET, COATED in 1 BOTTLE (50090-6539-1) | 2023-06-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Spironolactone | A-S Medication Solutions | 2025-11-19 | HUMAN PRESCRIPTION DRUG LABEL | 5 |