Spironolactone
- Product NDC
- 55154-5517
- 11-digit product format
- 551545517
- Labeler code
- 55154
- Product ID
- 55154-5517_a9817df4-41df-499d-9d7d-46daee4e514e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA040424
- Marketing category
- ANDA
- Marketing start
- 2011-02-04
- 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 | 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-5517-0 | Spironolactone | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 21 |
| 55154-5517-0 | Spironolactone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| AMMONIUM LAURETH-5 SULFATE | INACTIVE INGREDIENT | 43ZIH89I48 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| CALCIUM SULFATE DIHYDRATE | INACTIVE INGREDIENT | 4846Q921YM | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-5517 | SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240913_48115c9e-c82f-438d-b178-dce1b73687db.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 |
|---|
| 55154-5517-0 | 55154551700 | 10 BLISTER PACK in 1 BAG (55154-5517-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-02-04 | 0000-00-00 | No | No | Current |