Spironolactone
- Product NDC
- 60760-771
- Requested package NDC
- 60760-771-90
- 11-digit product format
- 607600771
- Labeler code
- 60760
- Product ID
- 60760-771_7b069009-00e1-10c2-e053-2991aa0aca3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA203512
- Marketing category
- ANDA
- Marketing start
- 2018-09-27
- Marketing end
- 0000-00-00
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 package | package | 60760-771 | 60760-771-90 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203512-001 | SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | |
| A203512-002 | SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | |
| A203512-003 | SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203512-001 | AB |
| A203512-002 | AB |
| A203512-003 | 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 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203512-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 2016-09-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203512-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 2016-09-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203512-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 2016-09-19 | 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 | A203512-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203512-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203512-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203512-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203512-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203512-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203512-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203512-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203512-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203512-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203512-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203512-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203512-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203512-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203512-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203512-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203512-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-771-90 | EA - Each | 60760-771 | 6a33ca22-db77-44d7-9101-8e0d89ae00b1 | 1 | 2018-11-06 |
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 | PD-Rx Pharmaceuticals, Inc. | 3487305c-25a6-4e82-923c-3e4dd638c988 | 2026-05-28 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Bryant Ranch Prepack | 473dc80f-11b7-46bf-b0b4-7a271444fca2 | 2026-05-21 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | c223a334-7383-429f-b8e3-a21200f16962 | 2026-05-21 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Bryant Ranch Prepack | 2ed347bc-a9f1-4800-99bc-9af9912ead1f | 2026-05-19 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Bryant Ranch Prepack | 650bf1c1-b7f1-4e5b-a9f0-3a2e31b98dd3 | 2026-05-14 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Northwind Health Company, LLC | ab3090fc-458c-17c1-e053-2995a90a6ffa | 2026-01-01 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Accord Healthcare, Inc. | 8a96e2c9-049a-43ab-abf3-21baedeb736f | 2025-12-01 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | c0efa529-2870-4260-b604-2f30e2cbb87b | 2025-10-17 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | NuCare Pharmaceuticals, Inc. | 540ee876-78fb-1792-e054-00144ff88e88 | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | NuCare Pharmaceuticals,Inc. | 691bc5ca-5d5e-60c2-e053-2991aa0abb93 | 2024-06-07 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Asclemed USA, Inc. | 31c42b3e-f076-49d9-aa61-6cef0dbb5543 | 2023-10-03 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Proficient Rx LP | dffac5dc-a111-4095-a96c-54cc5c3866e5 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | A-S Medication Solutions | 791251af-d276-40fc-8c35-9d179b20e219 | 2023-02-06 | Warnings, Adverse reactions | 203512 ANDA203512 |
| Spironolactone | SPIRONOLACTONE | Aphena Pharma Solutions - Tennessee, LLC | f230f1fa-878e-4753-a16c-bf059b59cdef | 2017-06-16 | Boxed warning, Warnings, Adverse reactions | 203512 ANDA203512 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-771-90 | 60760077190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-771-90) | 2018-09-27 | 0000-00-00 | No | No | Current |