Spironolactone
- Product NDC
- 76420-927
- 11-digit product format
- 764200927
- Labeler code
- 76420
- Product ID
- 76420-927_2fa991e8-8594-6911-e063-6294a90a916d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2021-01-04
- Substance
- SPIRONOLACTONE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198222, 198223, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-927-00 | Spironolactone | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 1 |
| 76420-927-01 | Spironolactone | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 1 |
| 76420-927-05 | Spironolactone | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 1 |
| 76420-927-30 | Spironolactone | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 1 |
| 76420-927-60 | Spironolactone | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 1 |
| 76420-927-90 | Spironolactone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-927 | SPIRONOLACTONE TABLET, COATED [ASCLEMED USA, INC.] | 1 | Current NDC, 6 package rows | 20250311_db22e9e5-2d88-4712-a809-c00881edb447.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-927-00 | 76420092700 | 1000 TABLET, COATED in 1 BOTTLE (76420-927-00) | 2025-03-06 | No | No | Historical |
| 76420-927-01 | 76420092701 | 100 TABLET, COATED in 1 BOTTLE (76420-927-01) | 2025-03-06 | No | No | Historical |
| 76420-927-05 | 76420092705 | 500 TABLET, COATED in 1 BOTTLE (76420-927-05) | 2025-03-06 | No | No | Historical |
| 76420-927-30 | 76420092730 | 30 TABLET, COATED in 1 BOTTLE (76420-927-30) | 2025-03-06 | No | No | Historical |
| 76420-927-60 | 76420092760 | 60 TABLET, COATED in 1 BOTTLE (76420-927-60) | 2025-03-06 | No | No | Historical |
| 76420-927-90 | 76420092790 | 90 TABLET, COATED in 1 BOTTLE (76420-927-90) | 2025-03-06 | No | No | Historical |