SPIRONOLACTONE
- Product NDC
- 63629-8539
- 11-digit product format
- 636298539
- Labeler code
- 63629
- Product ID
- 63629-8539_51af47bc-5caa-4dbd-8e99-f35b4bc07695
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 1986-07-23
- 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 |
|---|
| 63629-8539-1 | SPIRONOLACTONE | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 109 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8539 | SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK] | 108 | Current NDC, Legacy NDC, 1 package rows | 20240814_753bbc6f-2e50-49c1-b5bf-18f8411a1e8e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8539-1 | 63629853901 | 1000 TABLET in 1 BOTTLE, PLASTIC (63629-8539-1) | 1000 tablet | 1996-07-23 | 0000-00-00 | No | No | Current |