SPIRONOLACTONE
- Product NDC
- 70518-0563
- 11-digit product format
- 705180563
- Labeler code
- 70518
- Product ID
- 70518-0563_e1f45f58-39dc-b95a-e053-2a95a90acae6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 2017-06-02
- Marketing end
- 0000-00-00
- Substance
- SPIRONOLACTONE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 70518-0563 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70518-0563 | 70518-0563-0 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 70518-0563 | 70518-0563-1 | D | Discontinued by firm | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|---|
| A089424-001 | SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | |
| A089424-002 | SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | |
| A089424-003 | SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A089424-001 | AB |
| A089424-002 | AB |
| A089424-003 | 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 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089424-002 | SPIRONOLACTONE | 50MG | TABLET / ORAL | AB | 1999-08-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089424-003 | SPIRONOLACTONE | 100MG | TABLET / ORAL | AB | 1999-08-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089424-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | AB | 1986-07-23 | 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 | A089424-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A089424-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A089424-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A089424-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A089424-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A089424-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A089424-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A089424-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A089424-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089424-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089424-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089424-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A089424-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A089424-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A089424-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089424-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089424-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089424-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089424-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089424-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089424-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089424-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089424-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089424-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089424-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089424-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089424-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089424-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089424-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089424-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089424-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089424-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089424-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A089424-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A089424-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A089424-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089424-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089424-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089424-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089424-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-0563 | SPIRONOLACTONE TABLET, FILM COATED [REMEDYREPACK INC.] | 11 | Legacy NDC | 20250429_a55636c9-e114-47cc-be19-d2cda6efda23.zip |
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 | Bryant Ranch Prepack | 10a5c989-66e3-494d-bfd8-b2d6df3be411 | 2026-05-15 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | cae68fd6-5161-4650-bcde-6db98cbe6c8b | 2026-04-03 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d | 2026-04-02 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | 3791d79c-d960-4790-b689-ea32ddf7226a | 2026-03-30 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | cbc817de-5ea8-4139-9c13-02bac8ff93c3 | 2026-03-27 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | d4cf1136-df3a-4fc2-9a21-9032949eca41 | 2026-01-22 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Aphena Pharma Solutions - Tennessee, LLC | 45232668-6952-80a0-e063-6294a90a6e4b | 2025-12-17 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Aphena Pharma Solutions - Tennessee, LLC | fb961096-edbb-45ad-96b7-61c2f9b98cf9 | 2023-10-31 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Proficient Rx LP | 416ce231-fc8d-4ba0-a1ce-d5e054cf025e | 2023-08-01 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | A-S Medication Solutions | be568fbd-3c3d-417c-ae96-75a78ca4b7cd | 2023-06-02 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | A-S Medication Solutions | 4514fa40-613e-46f5-bee4-3edc7cc9863f | 2023-04-16 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | A-S Medication Solutions | 200b2a6a-f263-463e-a2e1-f4f74058a924 | 2023-04-07 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Asclemed USA, Inc. | 731894f2-bb1b-4ff6-b8c4-b8722e173199 | 2023-04-07 | Warnings, Adverse reactions | 089424 ANDA089424 |
| SPIRONOLACTONE | SPIRONOLACTONE | Proficient Rx LP | 18f11eed-9ef6-43f6-8db0-720c27563871 | 2023-04-01 | Warnings, Adverse reactions | 089424 ANDA089424 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-0563-1 | 70518056301 | 100 POUCH in 1 BOX (70518-0563-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-0563-2) | 100 pouch | 2021-08-30 | 0000-00-00 | No | No | Current |