SPIRONOLACTONE
- Product NDC
- 70518-4350
- 11-digit product format
- 705184350
- Labeler code
- 70518
- Product ID
- 70518-4350_373a9dc9-0c55-eb9a-e063-6394a90af4f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 2025-05-30
- 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 |
|---|
| 70518-4350-0 | 70518435000 | 100 POUCH in 1 BOX (70518-4350-0) / 1 TABLET in 1 POUCH (70518-4350-1) | 100 pouch | 2025-05-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SPIRONOLACTONE | REMEDYREPACK INC. | 2025-06-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |