Spironolactone
- Product NDC
- 72189-496
- 11-digit product format
- 721890496
- Labeler code
- 72189
- Product ID
- 72189-496_2c4e3f99-d912-b742-e063-6294a90a5d1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2023-07-06
- Substance
- SPIRONOLACTONE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198223 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-496-30 | Spironolactone | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 3 |
| 72189-496-90 | Spironolactone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-496 | SPIRONOLACTONE TABLET, COATED [DIRECT_RX] | 3 | Current NDC, 2 package rows | 20250123_ffd1ed7a-b6a4-4240-e053-6394a90a7db1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-496-30 | 72189049630 | 30 TABLET, COATED in 1 BOTTLE (72189-496-30) | 2023-07-06 | No | No | Current |
| 72189-496-90 | 72189049690 | 90 TABLET, COATED in 1 BOTTLE (72189-496-90) | 2023-07-06 | No | No | Current |