Spironolactone
- Product NDC
- 10544-499
- 11-digit product format
- 105440499
- Labeler code
- 10544
- Product ID
- 10544-499_10538860-d9ae-6cfd-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA091426
- Marketing category
- ANDA
- Marketing start
- 2014-02-12
- Marketing end
- 0000-00-00
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 10544-499-90 | Spironolactone | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-499 | SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150302_10538860-d9ad-6cfd-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-499-90 | 10544049990 | 90 in 1 BOTTLE | Historical |