Aldactone
- Product NDC
- 0025-1041
- 11-digit product format
- 000251041
- Labeler code
- 0025
- Product ID
- 0025-1041_22946678-dcad-4518-9bc6-cbdf51a38c16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA012151
- Marketing category
- NDA
- Marketing start
- 1960-01-21
- 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
- Aldactone
- 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 | 198222, 198223, 200817, 200820, 200825, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0025-1041-31 | Aldactone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| CALCIUM SULFATE DIHYDRATE | INACTIVE INGREDIENT | 4846Q921YM | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0025-1041 | ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 24 | Current NDC, Legacy NDC, 1 package rows | 20241225_0fed2822-3a03-4b64-9857-c682fcd462bc.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 |
|---|
| 0025-1041-31 | 00025104131 | 100 TABLET, FILM COATED in 1 BOTTLE (0025-1041-31) | 1960-01-21 | 0000-00-00 | No | No | Current |