Spironolactone
- Product NDC
- 64980-708
- 11-digit product format
- 649800708
- Labeler code
- 64980
- Product ID
- 64980-708_198e8618-c012-4f1c-9365-84c1829893c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA219494
- Marketing category
- ANDA
- Marketing start
- 2025-09-15
- Substance
- SPIRONOLACTONE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198222, 198223, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64980-708-01 | Spironolactone | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 64980-708-50 | Spironolactone | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64980-708-01 | 64980070801 | 100 TABLET in 1 BOTTLE (64980-708-01) | 100 tablet | 2025-09-15 | No | No | Current |
| 64980-708-50 | 64980070850 | 500 TABLET in 1 BOTTLE (64980-708-50) | 500 tablet | 2025-09-15 | No | No | Current |