NDC 68788-8381-03 - Spironolactone
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68788-8381
- Requested NDC
- 68788-8381-03
- Package NDCs from labels
- 68788-8381-3, 68788-8381-6, 68788-8381-9, 68788-8381-03
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Effective date
- 2025-09-24
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Spironolactone - Preferred Pharmaceuticals, Inc | Preferred Pharmaceuticals, Inc | 2025-09-24 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8381-3 | Spironolactone | 30 in 1 BOTTLE | TABLET, COATED | 30 | 3 | |
| 68788-8381-6 | Spironolactone | 60 in 1 BOTTLE | TABLET, COATED | 60 | 3 | |
| 68788-8381-9 | Spironolactone | 90 in 1 BOTTLE | TABLET, COATED | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8381 | SPIRONOLACTONE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC] | 2 | Current NDC, 3 package rows | 20240814_b68235bb-0940-4810-bbf4-2a7a0881de68.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8381-3 | EA - Each | 68788-8381 | 49a66d25-cc2b-4d9d-b408-bd4bc3811945 | 1 | 2023-06-06 |
| 68788-8381-6 | EA - Each | 68788-8381 | 06b14247-f2d2-47e6-b5ac-0a20786ee6b7 | 1 | 2023-06-06 |
| 68788-8381-9 | EA - Each | 68788-8381 | c44bed56-a52b-4366-a73a-c22efabd94fa | 1 | 2023-06-06 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 8b76a904-6c99-485a-a05f-13a36c5f720c | 2026-09-15 | Warnings, Adverse reactions | 198222 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | 3b60de71-2afa-4922-ba3e-0664c2ae29a0 | 2026-09-09 | Warnings, Adverse reactions | 198223 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | d6138536-cdc1-4459-84ff-9dedc0de1105 | 2026-09-09 | Warnings, Adverse reactions | 313096 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | caf41e17-0461-4667-9eab-62853b945131 | 2026-09-09 | Warnings, Adverse reactions | 198223 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | a6e0bf0e-42d3-41e4-854b-811df3bbaaa9 | 2026-09-09 | Warnings, Adverse reactions | 198223 27O7W4T232 |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | W Aesthetics | 5b0f2c8f-d6fa-5e25-e063-6394a90a084d | 2026-09-09 | Warnings | 15FIX9V2JP |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | 1fe93db1-0012-4ff6-a4e6-04e2d7e9f638 | 2026-09-09 | Warnings, Adverse reactions | 198222 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | 1b29888c-09f9-4cd5-9b4c-920bd159a727 | 2026-09-09 | Warnings, Adverse reactions | 313096 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | b98b7780-e310-493a-83bd-bb3d93cf8dde | 2026-09-09 | Warnings, Adverse reactions | 313096 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | 753bbc6f-2e50-49c1-b5bf-18f8411a1e8e | 2026-09-09 | Warnings, Adverse reactions | 313096 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | 0cc23419-e6d5-4036-8011-dc1d2455e0cb | 2026-09-09 | Warnings, Adverse reactions | 198222 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | REMEDYREPACK INC. | 7c59e03a-b058-4f6e-b104-0836d9b56392 | 2026-09-08 | Warnings, Adverse reactions | 313096 27O7W4T232 |
| Spironolactone | SPIRONOLACTONE | Preferred Pharmaceuticals Inc. | 5e456f3c-f93e-41c6-80c5-a737ed70feda | 2026-08-31 | Warnings, Adverse reactions | ANDA040750 198223 27O7W4T232 |
| Spironolactone | SPIRONOLACTONE | Preferred Pharmaceuticals Inc. | 4290b3ec-8993-47d4-bfe3-fcb81d7baed8 | 2026-08-31 | Warnings, Adverse reactions | ANDA040750 313096 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Atlantic Biologicals Corp. | 5a203ae4-0ed1-0099-e063-6294a90abc85 | 2026-08-28 | Warnings, Adverse reactions | 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Preferred Pharmaceuticals Inc. | 3486d831-06b6-4e8f-bd6f-52f7759988f5 | 2026-08-27 | Warnings, Adverse reactions | 198222 27O7W4T232 |
| MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50 | SUNSCREEN SPF50 | Guangzhou Meixi Biotechnology Co., Ltd. | 5a0b4bd2-f6ad-35dc-e063-6294a90a8a66 | 2026-08-27 | Warnings | 15FIX9V2JP |
| MELAO Hydrating Lightweight Sunscreen | AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE | Guangdong Aimu Biological Technology Co., Ltd | 59eeaea1-d726-99f3-e063-6394a90aeea3 | 2026-08-26 | Warnings | 15FIX9V2JP |
| SPIRONOLACTONE | SPIRONOLACTONE | ATLANTIC BIOLOGICALS CORP. | 122558a0-57bb-4195-9adf-d37b049cbfb5 | 2026-08-26 | Warnings, Adverse reactions | 27O7W4T232 |
| SPIRONOLACTONE | SPIRONOLACTONE | Redpharm Drug | 59d86d3a-0f94-0b04-e063-6294a90a83f3 | 2026-08-25 | Warnings, Adverse reactions | 313096 27O7W4T232 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.