Spironolactone
- Product NDC
- 51079-980
- 11-digit product format
- 510790980
- Labeler code
- 51079
- Product ID
- 51079-980_3a873ff3-7c53-afd9-e063-6294a90a155f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA040424
- Marketing category
- ANDA
- Marketing start
- 2002-02-20
- Substance
- SPIRONOLACTONE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198222, 198223, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51079-980-01 | Spironolactone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 11 |
| 51079-980-08 | Spironolactone | 80 in 1 CARTON | TABLET, FILM COATED | 80 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| CALCIUM SULFATE DIHYDRATE | INACTIVE INGREDIENT | 4846Q921YM | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-980 | SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231228_7e1a8152-941a-4aa4-bcb0-83c04905678f.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 |
|---|
| 51079-980-01 | 51079098001 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-980-08 | 51079098008 | 80 BLISTER PACK in 1 CARTON (51079-980-08) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-980-01) | 80 blister pack | 2002-02-20 | 0000-00-00 | No | No | Current |