Spironolactone
- Product NDC
- 68071-3375
- 11-digit product format
- 680713375
- Labeler code
- 68071
- Product ID
- 68071-3375_1ce8f03a-6918-908c-e063-6394a90a270c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA203512
- Marketing category
- ANDA
- Marketing start
- 2017-07-11
- 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 | 313096 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3375-1 | 2024-07-10 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-3 | 2024-07-10 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-6 | 2024-07-10 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-8 | 2024-07-10 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-9 | 2024-07-10 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-8 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
| 68071-3375-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4e1d-a910-e053-dadaa90a0b85 | Spironolactone tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3375-1 | Spironolactone | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 4 |
| 68071-3375-3 | Spironolactone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68071-3375-6 | Spironolactone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68071-3375-8 | Spironolactone | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 4 |
| 68071-3375-9 | Spironolactone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3375 | SPIRONOLACTONE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20240711_540ee876-78fb-1792-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3375-1 | 68071337501 | 120 TABLET, FILM COATED in 1 BOTTLE (68071-3375-1) | 2017-07-11 | No | No | Current |
| 68071-3375-3 | 68071337503 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3375-3) | 2017-07-11 | No | No | Current |
| 68071-3375-6 | 68071337506 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3375-6) | 2017-07-11 | No | No | Current |
| 68071-3375-8 | 68071337508 | 180 TABLET, FILM COATED in 1 BOTTLE (68071-3375-8) | 2017-07-11 | No | No | Current |
| 68071-3375-9 | 68071337509 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3375-9) | 2017-07-11 | No | No | Current |