Spironolactone
- Product NDC
- 16729-225
- 11-digit product format
- 167290225
- Labeler code
- 16729
- Product ID
- 16729-225_44e7bdd1-ae77-4b63-e063-6294a90a2c28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA203512
- Marketing category
- ANDA
- Marketing start
- 2017-06-02
- Substance
- SPIRONOLACTONE
- Active strength
- 25 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 | 25 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 |
|---|
| 16729-225-01 | Spironolactone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 16729-225-16 | Spironolactone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 16729-225-17 | Spironolactone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
| 16729-225-19 | Spironolactone | 2500 in 1 BOTTLE | TABLET, FILM COATED | 2500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-225 | SPIRONOLACTONE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20240216_8a96e2c9-049a-43ab-abf3-21baedeb736f.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 |
|---|
| 16729-225-01 | 16729022501 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-225-01) | 2017-06-02 | 0000-00-00 | No | No | Current |
| 16729-225-16 | 16729022516 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-225-16) | 2017-06-02 | 0000-00-00 | No | No | Current |
| 16729-225-17 | 16729022517 | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-225-17) | 2017-06-15 | 0000-00-00 | No | No | Current |
| 16729-225-19 | 16729022519 | 2500 in 1 BOTTLE | | | | | Historical |