spironolactone
- Product NDC
- 68382-661
- 11-digit product format
- 683820661
- Labeler code
- 68382
- Product ID
- 68382-661_79b8df9c-5a73-432e-bd16-bbbecd9e2046
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA205936
- Marketing category
- ANDA
- Marketing start
- 2018-08-15
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-661-01 | spironolactone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 68382-661-05 | spironolactone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 68382-661-06 | spironolactone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 68382-661-10 | spironolactone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
| 68382-661-16 | spironolactone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
| 68382-661-30 | spironolactone | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
| 68382-661-30 | spironolactone | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-661 | SPIRONOLACTONE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 6 | Current NDC, Legacy NDC, 7 package rows | 20230919_99bbc053-0e41-4b4d-979a-db610908f2de.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 |
|---|
| 68382-661-01 | 68382066101 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-661-01) | | 2018-08-15 | 0000-00-00 | No | No | Current |
| 68382-661-05 | 68382066105 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-661-05) | | 2018-08-15 | 0000-00-00 | No | No | Current |
| 68382-661-06 | 68382066106 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-661-06) | | 2018-08-15 | 0000-00-00 | No | No | Current |
| 68382-661-10 | 68382066110 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-661-10) | | 2018-08-15 | 0000-00-00 | No | No | Current |
| 68382-661-16 | 68382066116 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-661-16) | | 2018-08-15 | 0000-00-00 | No | No | Current |
| 68382-661-30 | 68382066130 | 10 BLISTER PACK in 1 CARTON (68382-661-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2018-08-15 | 0000-00-00 | No | No | Current |