Spironolactone
- Product NDC
- 59746-216
- 11-digit product format
- 597460216
- Labeler code
- 59746
- Product ID
- 59746-216_7839b797-5078-4aab-93a5-6056e4b9cdd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmacuticals Inc.
- Application
- ANDA203253
- Marketing category
- ANDA
- Marketing start
- 2013-02-01
- Substance
- SPIRONOLACTONE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198222, 198223, 313096 |
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 |
|---|
| 59746-216-01 | Spironolactone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 59746-216-05 | Spironolactone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 59746-216-10 | Spironolactone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
| 59746-216-06 | Spironolactone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 59746-216-09 | Spironolactone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 59746-216-15 | Spironolactone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| spironolactone | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| spironolactone | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| calcium sulfate | INACTIVE INGREDIENT | WAT0DDB505 | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Calcium Sulfate Dihydrate | INACTIVE INGREDIENT | 4846Q921YM | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Peppermint | INACTIVE INGREDIENT | V95R5KMY2B | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59746-216 | SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240728_a7510768-8a52-4230-6aa0-b0d92d82588f.zip |
| 59746-216 | SPIRONOLACTONE TABLET, FILM COATED SPIRONOLACTONE TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20240810_c1c5fdab-3ff7-414b-8e25-beed8311b8ad.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 |
|---|
| 59746-216-01 | 59746021601 | 100 TABLET, FILM COATED in 1 BOTTLE (59746-216-01) | 2017-04-04 | 0000-00-00 | No | No | Current |
| 59746-216-05 | 59746021605 | 500 TABLET, FILM COATED in 1 BOTTLE (59746-216-05) | 2017-04-04 | 0000-00-00 | No | No | Current |
| 59746-216-06 | 59746021606 | 100 TABLET, FILM COATED in 1 BOTTLE (59746-216-06) | 2017-04-04 | | No | No | Historical |
| 59746-216-09 | 59746021609 | 500 TABLET, FILM COATED in 1 BOTTLE (59746-216-09) | 2017-04-04 | | No | No | Historical |
| 59746-216-10 | 59746021610 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-216-10) | 2017-04-04 | 0000-00-00 | No | No | Current |
| 59746-216-15 | 59746021615 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-216-15) | 2017-04-04 | | No | No | Historical |