Spironolactone
- Product NDC
- 55154-5517
- 11-digit product format
- 551545517
- Labeler code
- 55154
- Product ID
- 55154-5517_a9817df4-41df-499d-9d7d-46daee4e514e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA040424
- Marketing category
- ANDA
- Marketing start
- 2011-02-04
- 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 |
|---|
| 55154-5517-0 | 55154551700 | 10 BLISTER PACK in 1 BAG (55154-5517-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-02-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Spironolactone | Cardinal Health 107, LLC | 2025-11-05 | HUMAN PRESCRIPTION DRUG LABEL | 21 |
| Spironolactone | Cardinal Health 107, LLC | 2024-09-11 | HUMAN PRESCRIPTION DRUG LABEL | 20 |