Spironolactone
- Product NDC
- 72789-291
- 11-digit product format
- 727890291
- Labeler code
- 72789
- Product ID
- 72789-291_43f46075-2020-1efb-e063-6394a90a42bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2021-01-04
- 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 |
|---|
| 72789-291-30 | Spironolactone | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 12 |
| 72789-291-60 | Spironolactone | 60 in 1 BOTTLE, PLASTIC | TABLET, COATED | 60 | | 12 |
| 72789-291-82 | Spironolactone | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | | 12 |
| 72789-291-90 | Spironolactone | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-291 | SPIRONOLACTONE TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20241207_8a66d90e-5450-4716-8c01-e7dc1967d00d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72789-291-30 | 72789029130 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-30) | 2022-12-12 | 0000-00-00 | No | No | Current |
| 72789-291-60 | 72789029160 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-60) | 2022-12-12 | 0000-00-00 | No | No | Current |
| 72789-291-82 | 72789029182 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-82) | 2022-12-12 | 0000-00-00 | No | No | Current |
| 72789-291-90 | 72789029190 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-90) | 2022-12-12 | 0000-00-00 | No | No | Current |