Spironolactone
- Product NDC
- 53746-514
- 11-digit product format
- 537460514
- Labeler code
- 53746
- Product ID
- 53746-514_0b757d66-e1f0-4d56-bbe0-2f0941f0a35e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA091426
- Marketing category
- ANDA
- Marketing start
- 2010-08-02
- 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
- 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, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POLYETHYLENE GLYCOL 3000 | INACTIVE INGREDIENT | SA1B764746 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-514 | SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 19 | Current NDC, Legacy NDC, 6 package rows | 20241003_951b8948-dc0f-4aef-9910-82c252de936d.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 |
|---|
| 53746-514-01 | 53746051401 | 100 TABLET in 1 BOTTLE (53746-514-01) | 100 tablet | 2010-08-02 | 0000-00-00 | No | No | Current |
| 53746-514-05 | 53746051405 | 500 TABLET in 1 BOTTLE (53746-514-05) | 500 tablet | 2010-08-02 | 0000-00-00 | No | No | Current |
| 53746-514-10 | 53746051410 | 1000 TABLET in 1 BOTTLE (53746-514-10) | 1000 tablet | 2010-08-02 | 0000-00-00 | No | No | Current |
| 53746-514-30 | 53746051430 | 30 TABLET in 1 BOTTLE (53746-514-30) | 30 tablet | 2010-08-02 | 0000-00-00 | No | No | Current |
| 53746-514-60 | 53746051460 | 60 TABLET in 1 BOTTLE (53746-514-60) | 60 tablet | 2010-08-02 | 0000-00-00 | No | No | Current |
| 53746-514-90 | 53746051490 | 90 TABLET in 1 BOTTLE (53746-514-90) | 90 tablet | 2010-08-02 | 0000-00-00 | No | No | Current |