Spironolactone
- Product NDC
- 43063-835
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA203512
- Marketing category
- ANDA
- Substance
- SPIRONOLACTONE
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 43063-835-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-30) | 2018-02-13 | No | Historical | |
| 43063-835-90 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-90) | 2018-03-07 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960 | PD-Rx Pharmaceuticals, Inc. | 2025-10-17 | HUMAN PRESCRIPTION DRUG LABEL | 17 |
| These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960 | PD-Rx Pharmaceuticals, Inc. | 2024-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 16 |