Spironolactone
- Product NDC
- 21695-960
- 11-digit product format
- 216950960
- Labeler code
- 21695
- Product ID
- 21695-960_e5bf608e-c6dd-44e8-96aa-ba4660f64de0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2006-08-29
- Marketing end
- 0000-00-00
- Substance
- SPIRONOLACTONE
- Active strength
- 50 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 |
|---|
| 21695-960-60 | Spironolactone | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-960 | SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110914_e5bf608e-c6dd-44e8-96aa-ba4660f64de0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-960-60 | 21695096060 | 60 in 1 BOTTLE, PLASTIC | Historical |