Spironolactone
- Product NDC
- 67544-310
- 11-digit product format
- 675440310
- Labeler code
- 67544
- Product ID
- 67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040424
- Marketing category
- ANDA
- Marketing start
- 1981-02-03
- Substance
- SPIRONOLACTONE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-310-30 | Spironolactone | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 67544-310-45 | Spironolactone | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 3 |
| 67544-310-60 | Spironolactone | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-310 | SPIRONOLACTONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20211016_1c97ce61-8e49-4724-a636-d179479d346c.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 |
|---|
| 67544-310-30 | 67544031030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30) | 2014-12-19 | 0000-00-00 | No | No | Current |
| 67544-310-45 | 67544031045 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45) | 2021-09-09 | 0000-00-00 | No | No | Current |
| 67544-310-60 | 67544031060 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60) | 2014-12-19 | 0000-00-00 | No | No | Current |