Spironolactone
- Product NDC
- 63187-861
- 11-digit product format
- 631870861
- Labeler code
- 63187
- Product ID
- 63187-861_d5bfc979-a820-4d06-ab41-9ccbaf28a914
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203253
- Marketing category
- ANDA
- Marketing start
- 2013-02-01
- 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 |
|---|
| 63187-861-30 | Spironolactone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 63187-861-60 | Spironolactone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 63187-861-90 | Spironolactone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-861 | SPIRONOLACTONE TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191113_caf9c845-63eb-40bd-8261-0582abdf705a.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 |
|---|
| 63187-861-30 | 63187086130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-861-30) | 2017-06-01 | 0000-00-00 | No | No | Current |
| 63187-861-60 | 63187086160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-861-60) | 2017-06-01 | 0000-00-00 | No | No | Current |
| 63187-861-90 | 63187086190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-861-90) | 2017-06-01 | 0000-00-00 | No | No | Current |