SPIRONOLACTONE
- Product NDC
- 68071-3795
- 11-digit product format
- 680713795
- Labeler code
- 68071
- Product ID
- 68071-3795_2e5e782d-9cec-d4a4-e063-6294a90aba3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA202187
- Marketing category
- ANDA
- Marketing start
- 2019-12-13
- 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 |
|---|
| 68071-3795-9 | SPIRONOLACTONE | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3795 | SPIRONOLACTONE TABLET [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250221_2e5e782d-9ceb-d4a4-e063-6294a90aba3a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3795-9 | 68071379509 | 90 TABLET in 1 BOTTLE (68071-3795-9) | 90 tablet | 2025-02-17 | No | No | Historical |