Spironolactone
- Product NDC
- 68084-208
- 11-digit product format
- 680840208
- Labeler code
- 68084
- Product ID
- 68084-208_6e9d9083-4d12-5101-e053-2991aa0a9cf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2010-02-15
- Marketing end
- 2019-07-31
- Substance
- SPIRONOLACTONE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68084-208 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 68084-208 | 68084-208-01 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68084-208-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68084-208-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68084-208-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68084-208-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68084-208-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68084-208-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68084-208-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68084-208-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68084-208-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68084-208-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68084-208-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68084-208-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040750-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2006-08-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040750-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2006-08-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040750-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2006-08-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040750-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040750-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040750-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040750-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040750-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040750-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-208-01 | EA - Each | 68084-208 | 02368f90-f429-4a9b-b24a-98a13eaa6566 | 1 | 2012-07-24 |
| 68084-208-11 | EA - Each | 68084-208 | c91e0b6a-fa94-4472-b057-d16f73b960b0 | 1 | 2012-07-24 |
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 | 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 | REMEDYREPACK INC. | b119ed8a-289a-46c5-9778-6b07e4c061c4 | 2026-06-01 | 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 | REMEDYREPACK INC. | 7646ca22-710e-4a5c-9613-b829e2f9d5ce | 2026-04-15 | 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 | bb29ea6f-c294-4895-9e9b-544d69651a35 | 2025-12-03 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | A-S Medication Solutions | c328f555-2da8-43ac-bc04-0e89d4d2aa53 | 2025-12-02 | 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 | A-S Medication Solutions | 08738ad4-1607-4d55-af71-6790477353bd | 2025-11-19 | Warnings, Adverse reactions | 040750 ANDA040750 |
| Spironolactone | SPIRONOLACTONE | Preferred Pharmaceuticals Inc. | 5e456f3c-f93e-41c6-80c5-a737ed70feda | 2025-09-24 | Warnings, Adverse reactions | 040750 ANDA040750 |