Spironolactone
- Product NDC
- 68071-3969
- 11-digit product format
- 680713969
- Labeler code
- 68071
- Product ID
- 68071-3969_4ba8699f-9367-245a-e063-6294a90a1377
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2021-01-04
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Spironolactone
- Listing expiration
- 2027-12-31
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 |
|---|
| 68071-3969-1 | Spironolactone | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3969-1 | 68071396901 | 100 TABLET, COATED in 1 BOTTLE (68071-3969-1) | 2026-02-24 | No | No | Historical |