Spironolactone
- Product NDC
- 67544-310
- 11-digit product format
- 675440310
- Labeler code
- 67544
- Product ID
- 67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040424
- Marketing category
- ANDA
- Marketing start
- 1981-02-03
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 67544-310-30 | 67544031030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30) | 2014-12-19 | No | No | Historical |
| 67544-310-45 | 67544031045 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45) | 2021-09-09 | No | No | Historical |
| 67544-310-60 | 67544031060 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60) | 2014-12-19 | No | No | Historical |