Spironolactone
- Product NDC
- 42708-126
- 11-digit product format
- 427080126
- Labeler code
- 42708
- Product ID
- 42708-126_5190401f-30e9-5394-e063-6294a90ab09b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- QPharma, Inc
- Application
- ANDA091426
- Marketing category
- ANDA
- Marketing start
- 2010-08-02
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42708-126-30 | Spironolactone | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42708-126 | SPIRONOLACTONE TABLET [QPHARMA, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241123_eb314e91-6dd5-4bdb-af35-5d147b20339c.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 |
|---|
| 42708-126-30 | 42708012630 | 30 TABLET in 1 BOTTLE (42708-126-30) | 30 tablet | 2018-05-23 | 0000-00-00 | Yes | No | Current |