Spironolactone
- Product NDC
- 53002-1707
- 11-digit product format
- 530021707
- Labeler code
- 53002
- Product ID
- 53002-1707_57446208-b1dc-4b64-87ab-11e55b7e7cb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA091426
- Marketing category
- ANDA
- Marketing start
- 2010-08-02
- Marketing end
- 0000-00-00
- Substance
- SPIRONOLACTONE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1707-0 | 53002170700 | 100 TABLET in 1 BOTTLE (53002-1707-0) | 100 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-1707-3 | 53002170703 | 30 TABLET in 1 BOTTLE (53002-1707-3) | 30 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-1707-6 | 53002170706 | 60 TABLET in 1 BOTTLE (53002-1707-6) | 60 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Spironolactone | RPK Pharmaceuticals, Inc. | 2023-06-07 | HUMAN PRESCRIPTION DRUG LABEL | 3 |