SPIRONOLACTONE
- Product NDC
- 71610-970
- 11-digit product format
- 716100970
- Labeler code
- 71610
- Product ID
- 71610-970_462bf397-a6df-e7a9-e063-6294a90afb60
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPIRONOLACTONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SPIRONOLACTONE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-970-30 | SPIRONOLACTONE | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 71610-970-45 | SPIRONOLACTONE | 45 in 1 BOTTLE | TABLET | 45 | | 2 |
| 71610-970-60 | SPIRONOLACTONE | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 71610-970-80 | SPIRONOLACTONE | 180 in 1 BOTTLE | TABLET | 180 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-970-30 | 71610097030 | 30 TABLET in 1 BOTTLE (71610-970-30) | 30 tablet | 2025-12-16 | No | No | Current |
| 71610-970-45 | 71610097045 | 45 TABLET in 1 BOTTLE (71610-970-45) | 45 tablet | 2025-12-03 | No | No | Current |
| 71610-970-60 | 71610097060 | 90 TABLET in 1 BOTTLE (71610-970-60) | 90 tablet | 2025-12-03 | No | No | Current |
| 71610-970-80 | 71610097080 | 180 TABLET in 1 BOTTLE (71610-970-80) | 180 tablet | 2025-12-03 | No | No | Current |