SPIRONOLACTONE
- Product NDC
- 59651-427
- 11-digit product format
- 596510427
- Labeler code
- 59651
- Product ID
- 59651-427_9b6802a0-5117-4be3-a113-9098e8dcedaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202187
- Marketing category
- ANDA
- Marketing start
- 2019-12-13
- Substance
- SPIRONOLACTONE
- Active strength
- 50 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 | 50 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 |
|---|
| 59651-427-01 | SPIRONOLACTONE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 59651-427-05 | SPIRONOLACTONE | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-427 | SPIRONOLACTONE TABLET [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230829_768563dc-a619-44dc-b97f-1a7e71fd56a0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-427-01 | 59651042701 | 100 TABLET in 1 BOTTLE (59651-427-01) | 100 tablet | 2019-12-13 | 0000-00-00 | No | No | Current |
| 59651-427-05 | 59651042705 | 500 TABLET in 1 BOTTLE (59651-427-05) | 500 tablet | 2019-12-13 | 0000-00-00 | No | No | Current |