SPIRONOLACTONE
- Product NDC
- 68071-2989
- 11-digit product format
- 680712989
- Labeler code
- 68071
- Product ID
- 68071-2989_2d53de10-d7af-f4b7-e063-6294a90a92c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202187
- Marketing category
- ANDA
- Marketing start
- 2019-12-13
- 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 |
|---|
| 68071-2989-3 | 68071298903 | 30 TABLET in 1 BOTTLE (68071-2989-3) | 30 tablet | 2023-04-19 | No | No | Historical |
| 68071-2989-9 | 68071298909 | 90 TABLET in 1 BOTTLE (68071-2989-9) | 90 tablet | 2023-04-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SPIRONOLACTONE | NuCare Pharmaceuticals,Inc. | 2025-02-04 | HUMAN PRESCRIPTION DRUG LABEL | 3 |