Spironolactone
- Product NDC
- 53401-041
- 11-digit product format
- 534010041
- Labeler code
- 53401
- Product ID
- 53401-041_5d407dcd-e4fa-31b3-e063-6394a90a24e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2021-01-04
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040750-001 | SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | |
| A040750-002 | SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | |
| A040750-003 | SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040750-001 | AB |
| A040750-002 | AB |
| A040750-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040750-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040750-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040750-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040750-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040750-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040750-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040750-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040750-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040750-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040750-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040750-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040750-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040750-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040750-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040750-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040750-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040750-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040750-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040750-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040750-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040750-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040750-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040750-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040750-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040750-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040750-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040750-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040750-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040750-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040750-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040750-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040750-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040750-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040750-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040750-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040750-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040750-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040750-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040750-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040750-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Spironolactone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SPIRONOLACTONE | 25 mg/1 |
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 | Preferred Pharmaceuticals Inc. | 5e456f3c-f93e-41c6-80c5-a737ed70feda | 2026-08-31 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Preferred Pharmaceuticals Inc. | 4290b3ec-8993-47d4-bfe3-fcb81d7baed8 | 2026-08-31 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 7646ca22-710e-4a5c-9613-b829e2f9d5ce | 2026-08-17 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | b119ed8a-289a-46c5-9778-6b07e4c061c4 | 2026-08-14 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 73564b3d-8ede-4008-b75c-1277153b5bb6 | 2026-07-17 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 8a66d90e-5450-4716-8c01-e7dc1967d00d | 2026-07-17 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 8cbe2215-744c-438a-b3d6-b7d6ae769231 | 2026-07-17 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 8f0291a9-c8a6-4298-a540-23abc01fae09 | 2026-07-09 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Coupler LLC | 56050192-c499-64bd-e063-6294a90acbeb | 2026-07-07 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Coupler LLC | 53454970-2c0f-54c3-e063-6294a90aac0a | 2026-06-02 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Proficient Rx LP | 6782c1c1-d1ac-4c07-b7cb-a74699d2f9fe | 2026-05-01 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Proficient Rx LP | 6867776e-b4fd-41db-8da8-a5af76eed280 | 2026-04-01 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Direct_Rx | ffd2f3f5-c7c8-0028-e053-6394a90aaf17 | 2026-03-05 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | NuCare Pharmaceuticals,Inc. | 4b9a20c4-46f2-d572-e063-6294a90a30ad | 2026-02-25 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | NuCare Pharmaceuticals, Inc. | 4b4af7e0-f35b-9bf6-e063-6294a90a83b9 | 2026-02-20 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Oxford Pharmaceuticals, LLC | 852684dc-e1c6-4caa-bccb-10ac90bbb3bb | 2026-02-17 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Coupler LLC | 472ee2ad-7e57-bef1-e063-6394a90a0206 | 2025-12-30 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | A-S Medication Solutions | cd64e343-e15e-43b1-88b5-a3d5ba23fedf | 2025-11-26 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Preferred Pharmaceuticals, Inc | b68235bb-0940-4810-bbf4-2a7a0881de68 | 2025-09-24 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Asclemed USA, Inc. | db22e9e5-2d88-4712-a809-c00881edb447 | 2025-03-06 | Warnings, Adverse reactions | 040750 ANDA040750 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 53401-041-30 | 53401004130 | 30 TABLET, COATED in 1 BOTTLE (53401-041-30) | 2026-10-05 | No | No | Current |
| 53401-041-45 | 53401004145 | 45 TABLET, COATED in 1 BOTTLE (53401-041-45) | 2026-10-05 | No | No | Current |
| 53401-041-60 | 53401004160 | 90 TABLET, COATED in 1 BOTTLE (53401-041-60) | 2026-10-05 | No | No | Current |
| 53401-041-80 | 53401004180 | 180 TABLET, COATED in 1 BOTTLE (53401-041-80) | 2026-10-05 | No | No | Current |