Spironolactone
- Product NDC
- 50090-6539
- 11-digit product format
- 500906539
- Labeler code
- 50090
- Product ID
- 50090-6539_76b5d6ad-0b7b-4781-b990-5ba036cf5a67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6539-0 | Spironolactone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 5 |
| 50090-6539-1 | Spironolactone | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6539 | SPIRONOLACTONE TABLET, COATED [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, 2 package rows | 20230708_08738ad4-1607-4d55-af71-6790477353bd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6539-0 | 50090653900 | 90 TABLET, COATED in 1 BOTTLE (50090-6539-0) | 2023-06-29 | No | No | Current |
| 50090-6539-1 | 50090653901 | 30 TABLET, COATED in 1 BOTTLE (50090-6539-1) | 2023-06-29 | No | No | Current |