Spironolactone
- Product NDC
- 43063-974
- 11-digit product format
- 430630974
- Labeler code
- 43063
- Product ID
- 43063-974_415f6526-8f0e-7b23-e063-6294a90a0961
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA203512
- Marketing category
- ANDA
- Marketing start
- 2017-06-02
- 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
- 2027-12-31
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 |
|---|
| 43063-974-90 | Spironolactone | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-974 | SPIRONOLACTONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | Current NDC, Legacy NDC, 1 package rows | 20240710_3487305c-25a6-4e82-923c-3e4dd638c988.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 |
|---|
| 43063-974-90 | 43063097490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-974-90) | 2019-04-26 | 0000-00-00 | No | No | Current |