Spironolactone
- Product NDC
- 67046-1636
- 11-digit product format
- 670461636
- Labeler code
- 67046
- Product ID
- 67046-1636_472ef1b9-ede4-a39d-e063-6294a90ad566
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2025-12-30
- 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 |
|---|
| 67046-1636-3 | 67046163603 | 30 TABLET, COATED in 1 BLISTER PACK (67046-1636-3) | 2025-12-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Spironolactone | Coupler LLC | 2025-12-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |