Spironolactone
- Product NDC
- 82804-977
- 11-digit product format
- 828040977
- Labeler code
- 82804
- Product ID
- 82804-977_99b119e3-537a-464c-9376-4219bf283753
- 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
- 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 |
|---|
| 82804-977-00 | Spironolactone | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 1 |
| 82804-977-11 | Spironolactone | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 1 |
| 82804-977-30 | Spironolactone | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 1 |
| 82804-977-55 | Spironolactone | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 1 |
| 82804-977-60 | Spironolactone | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 1 |
| 82804-977-72 | Spironolactone | 120 in 1 BOTTLE | TABLET, COATED | 120 | | 1 |
| 82804-977-90 | Spironolactone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-977 | SPIRONOLACTONE TABLET, COATED [PROFICIENT RX LP] | 1 | Current NDC, 7 package rows | 20250216_99b119e3-537a-464c-9376-4219bf283753.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-977-00 | 82804097700 | 100 TABLET, COATED in 1 BOTTLE (82804-977-00) | 2025-02-13 | No | No | Current |
| 82804-977-11 | 82804097711 | 1000 TABLET, COATED in 1 BOTTLE (82804-977-11) | 2025-02-13 | No | No | Current |
| 82804-977-30 | 82804097730 | 30 TABLET, COATED in 1 BOTTLE (82804-977-30) | 2025-02-13 | No | No | Current |
| 82804-977-55 | 82804097755 | 500 TABLET, COATED in 1 BOTTLE (82804-977-55) | 2025-02-13 | No | No | Current |
| 82804-977-60 | 82804097760 | 60 TABLET, COATED in 1 BOTTLE (82804-977-60) | 2025-02-13 | No | No | Current |
| 82804-977-72 | 82804097772 | 120 TABLET, COATED in 1 BOTTLE (82804-977-72) | 2025-02-13 | No | No | Current |
| 82804-977-90 | 82804097790 | 90 TABLET, COATED in 1 BOTTLE (82804-977-90) | 2025-02-13 | No | No | Current |