spironolactone
- Product NDC
- 0904-6927
- 11-digit product format
- 009046927
- Labeler code
- 0904
- Product ID
- 0904-6927_c37ed479-700b-4d5c-b269-383f2d2f9fd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA205936
- Marketing category
- ANDA
- Marketing start
- 2018-08-15
- 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 |
|---|
| 0904-6927-61 | spironolactone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 7 |
| 0904-6927-61 | spironolactone | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6927 | SPIRONOLACTONE TABLET [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250216_0c45d793-6f2f-4622-b5ed-6875acfbc02b.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 |
|---|
| 0904-6927-61 | 00904692761 | 100 BLISTER PACK in 1 CARTON (0904-6927-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2018-08-15 | 0000-00-00 | No | No | Current |