SPIRONOLACTONE
- Product NDC
- 63629-1061
- 11-digit product format
- 636291061
- Labeler code
- 63629
- Product ID
- 63629-1061_c7111ac4-b6f1-40cb-b590-2dc77044202f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 1986-07-23
- Substance
- SPIRONOLACTONE
- Active strength
- 25 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-1061-1 | 63629106101 | 100 TABLET in 1 BOTTLE, PLASTIC (63629-1061-1) | 100 tablet | 1986-07-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SPIRONOLACTONE | REMEDYREPACK INC. | 2025-06-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| SPIRONOLACTONE | Bryant Ranch Prepack | 2024-10-30 | HUMAN PRESCRIPTION DRUG LABEL | 10 |