Spironolactone
- Product NDC
- 69584-853
- 11-digit product format
- 695840853
- Labeler code
- 69584
- Product ID
- 69584-853_70be7336-8f41-4960-b57d-7830ca020481
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Oxford Pharmaceuticals, LLC
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2021-01-04
- Substance
- SPIRONOLACTONE
- Active strength
- 50 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 | 50 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 |
|---|
| 69584-853-09 | Spironolactone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 4 |
| 69584-853-10 | Spironolactone | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 4 |
| 69584-853-50 | Spironolactone | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 4 |
| 69584-853-90 | Spironolactone | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69584-853 | SPIRONOLACTONE TABLET, COATED [OXFORD PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240405_852684dc-e1c6-4caa-bccb-10ac90bbb3bb.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 |
|---|
| 69584-853-09 | 69584085309 | 90 TABLET, COATED in 1 BOTTLE (69584-853-09) | 2026-02-17 | | No | No | Current |
| 69584-853-10 | 69584085310 | 100 TABLET, COATED in 1 BOTTLE (69584-853-10) | 2021-01-04 | 0000-00-00 | No | No | Current |
| 69584-853-50 | 69584085350 | 500 TABLET, COATED in 1 BOTTLE (69584-853-50) | 2021-01-04 | 0000-00-00 | No | No | Current |
| 69584-853-90 | 69584085390 | 1000 TABLET, COATED in 1 BOTTLE (69584-853-90) | 2024-04-01 | | No | No | Current |