SPIRONOLACTONE
- Product NDC
- 71610-742
- 11-digit product format
- 716100742
- Labeler code
- 71610
- Product ID
- 71610-742_affa2e96-25b1-435b-9668-82dcd7a5777e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 1986-07-23
- 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 |
|---|
| 71610-742-30 | 71610074230 | 30 TABLET in 1 BOTTLE, PLASTIC (71610-742-30) | 30 tablet | 2023-10-26 | No | No | Historical |
| 71610-742-45 | 71610074245 | 45 TABLET in 1 BOTTLE, PLASTIC (71610-742-45) | 45 tablet | 2023-10-10 | No | No | Historical |
| 71610-742-60 | 71610074260 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-742-60) | 90 tablet | 2023-10-10 | No | No | Historical |
| 71610-742-80 | 71610074280 | 180 TABLET in 1 BOTTLE, PLASTIC (71610-742-80) | 180 tablet | 2023-10-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SPIRONOLACTONE | Aphena Pharma Solutions - Tennessee, LLC | 2023-10-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |