Spironolactone
- Product NDC
- 76420-062
- 11-digit product format
- 764200062
- Labeler code
- 76420
- Product ID
- 76420-062_06c94882-1323-c834-e063-6394a90a2d75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA203512
- Marketing category
- ANDA
- Marketing start
- 2017-06-02
- 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 | 198223, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-062-01 | Spironolactone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 76420-062-30 | Spironolactone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 76420-062-60 | Spironolactone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 76420-062-90 | Spironolactone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-062 | SPIRONOLACTONE TABLET, FILM COATED [ASCLEMED USA, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20231004_31c42b3e-f076-49d9-aa61-6cef0dbb5543.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 |
|---|
| 76420-062-01 | 76420006201 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-062-01) | 2023-10-03 | | No | No | Historical |
| 76420-062-30 | 76420006230 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-062-30) | 2020-02-11 | 0000-00-00 | No | No | Current |
| 76420-062-60 | 76420006260 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-062-60) | 2023-10-03 | | No | No | Historical |
| 76420-062-90 | 76420006290 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-062-90) | 2023-10-03 | | No | No | Historical |