Spironolactone
- Product NDC
- 71610-287
- 11-digit product format
- 716100287
- Labeler code
- 71610
- Product ID
- 71610-287_37a5f19e-c2d2-4dde-9aa0-48d70f892e68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA203512
- Marketing category
- ANDA
- Marketing start
- 2017-06-02
- Substance
- SPIRONOLACTONE
- Active strength
- 50 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 |
|---|
| 71610-287-30 | 71610028730 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-287-30) | 2019-05-31 | No | No | Historical |
| 71610-287-45 | 71610028745 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-287-45) | 2019-05-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Spironolactone tablets, USP | Aphena Pharma Solutions - Tennessee, LLC | 2017-06-16 | HUMAN PRESCRIPTION DRUG LABEL | 1 |