Spironolactone
- Product NDC
- 82804-255
- 11-digit product format
- 828040255
- Labeler code
- 82804
- Product ID
- 82804-255_492183f2-b2a7-4164-90dd-99c26ab81518
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2021-01-04
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Spironolactone
- Listing expiration
- 2027-12-31
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 |
|---|
| 82804-255-30 | Spironolactone | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 2 |
| 82804-255-90 | Spironolactone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-255-30 | 82804025530 | 30 TABLET, COATED in 1 BOTTLE (82804-255-30) | 2025-11-12 | No | No | Current |
| 82804-255-90 | 82804025590 | 90 TABLET, COATED in 1 BOTTLE (82804-255-90) | 2026-05-14 | No | No | Current |