12 HR ranolazine 500 MG Extended Release Oral Tablet
- RxCUI
- 616749
- RxNorm name
- 12 HR ranolazine 500 MG Extended Release Oral Tablet
- Display name
- 12 HR ranolazine 500 MG Extended Release Oral Tablet
- Full name
- 12 HR ranolazine 500 MG Extended Release Oral Tablet
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:28
UNII Substances#
No records found.
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 |
|---|---|---|---|---|---|---|
| Ranolazine | RANOLAZINE | Proficient Rx LP | c7ed8234-e6bd-4f19-a1ce-40f272a79036 | 2024-07-01 | Warnings, Adverse reactions | 616749 |
| Ranolazine | RANOLAZINE | Aphena Pharma Solutions - Tennessee, LLC | abb32182-46ba-49d2-b2ac-13de2ecf802d | 2024-04-02 | Warnings, Adverse reactions | 616749 |
| Ranolazine | RANOLAZINE | Aurobindo Pharma Limited | 49873158-5c0a-41da-86a2-369ef6b0cbc8 | 2024-02-15 | Warnings, Adverse reactions | 616749 |
| RANOLAZINE | RANOLAZINE | Lupin Pharmaceuticals, Inc. | 595821d7-1fbf-49a5-9c62-d78f27af39b4 | 2023-12-08 | Warnings, Adverse reactions | 616749 |
| Ranolazine | RANOLAZINE | Unichem Pharmaceuticals (USA), Inc. | e2a8c9f9-5f6a-4496-8fd6-2439e564db4f | 2023-11-06 | Warnings, Adverse reactions | 616749 |
| Ranolazine | RANOLAZINE | Camber Pharmaceuticals, Inc. | 82948cdb-73af-4f3f-bd03-628ed0fdbfba | 2022-05-13 | Warnings, Adverse reactions | 616749 |
| RANOLAZINE | RANOLAZINE | i3 Pharmaceuticals, LLC | de3185bf-448a-15f7-e053-2995a90a9a2e | 2022-05-04 | Warnings, Adverse reactions | 616749 |
| Ranolazine | RANOLAZINE | Proficient Rx LP | 989e1688-a0b5-4297-bf91-234de2a0b445 | 2022-03-01 | Warnings, Adverse reactions | 616749 |
| Ranolazine | RANOLAZINE | Westminster Pharmaceuticals, LLC | b91e88a0-04d0-4d0d-92d8-966b27a48e29 | 2021-09-02 | Warnings, Adverse reactions | 616749 |
| Ranolazine | RANOLAZINE | Sun Pharmaceutical Industries, Inc. | c5848232-b7fd-4fe5-a543-16d6c4b5c0b1 | 2020-08-17 | Warnings, Adverse reactions | 616749 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| f3c09979-a44a-4197-97d2-29a207b6fc73 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 14 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260325 |
| 595821d7-1fbf-49a5-9c62-d78f27af39b4 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 11 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20231208 |
| 8bfd1a61-547a-4847-ae4e-480b17da6272 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 8 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20251028 |
| 195c4b51-fec2-410d-8d90-487c536a8728 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 7 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260506 |
| b2a8dc3e-a880-5241-e053-2995a90a933a | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 7 | RANOLAZINE Extended-Release Tablets Rx Only These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. Initial U.S. Approval: 2006 | 20260115 |
| 5b254a8e-db88-49be-bb48-e6d2847f8ab3 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 6 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets for oral use Initial U.S. Approval: 2006 | 20250728 |
| e2a8c9f9-5f6a-4496-8fd6-2439e564db4f | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 6 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval:2006 | 20231106 |
| 00979fb3-d70f-493d-94ca-2914cbadaa9d | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 5 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260129 |
| 0cf58732-c242-49b0-8e3f-248778b4458d | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 5 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260123 |
| 5f4fc8a4-2bd5-4378-8882-e739c951390e | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260421 |
| d74f3dea-7357-4e9a-be9a-2f498a44108a | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260129 |
| 71d50258-75b7-4801-b0f4-c34fe883d57d | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20241224 |
| de3185bf-448a-15f7-e053-2995a90a9a2e | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 4 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20220504 |
| f6facddc-c020-436e-8e68-bf9a4223e7cf | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20211123 |
| c5848232-b7fd-4fe5-a543-16d6c4b5c0b1 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20200817 |
| 90c5a0c2-542c-467e-9c0c-ef320534c560 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20241003 |
| e038f963-d78f-460e-a11f-46f224061505 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use RANEXA safely and effectively. See full prescribing information for RANEXA. RANEXA ® (ranolazine) extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20160806 |
| 38d2833d-44b8-8d46-e063-6394a90a74d8 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20260220 |
| e92350e8-5b0b-95d3-e053-2995a90a959b | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 2 | Ranolazine Extended Release Tablets Rx Only These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. Initial U.S. Approval: 2006 | 20260109 |
| 6166c40c-4fbe-47c4-92e4-2dc5d3567a86 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets for oral use Initial U.S. Approval: 2006 | 20251229 |
| abb32182-46ba-49d2-b2ac-13de2ecf802d | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 2 | RANOLAZINE Extended-Release Tablets Rx Only These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. Initial U.S. Approval: 2006 | 20240402 |
| 49873158-5c0a-41da-86a2-369ef6b0cbc8 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20240215 |
| 989e1688-a0b5-4297-bf91-234de2a0b445 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20220301 |
| 8d442b8c-97a8-40a9-8603-f9cd0542cedc | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use Ranexa safely and effectively. See full prescribing information for Ranexa. Ranexa (ranolazine) extended-release tablets Initial U.S. Approval: 2006 | 20100426 |
| d2454377-2abd-4d9f-85f1-12f1adbb10e5 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED–RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260415 |
| 2373687b-b9a4-496e-b89f-9754f8513fd3 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20260121 |
| 45236b7d-3728-1e13-e063-6394a90ad77f | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20251204 |
| 9fb62878-c76a-4be2-99be-962ce2956af2 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20250228 |
| 9199e28a-ddbe-46a4-ab26-9b08034289be | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20250123 |
| 2e678c80-1410-433b-8c48-4b210eceb0de | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20250117 |
| c7ed8234-e6bd-4f19-a1ce-40f272a79036 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20240701 |
| 82948cdb-73af-4f3f-bd03-628ed0fdbfba | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006 | 20220513 |
| b91e88a0-04d0-4d0d-92d8-966b27a48e29 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20210902 |
| c842805c-c78d-474e-8a33-c2e828bad800 | ranolazine 500 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR ranolazine 500 MG Extended Release Oral Tablet [SCD] · ranolazine 500 MG 12 HR Extended Release Oral Tablet [SY] | 3 | 1 | RANOLAZINE EXTENDED-RELEASE TABLETS These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006 | 20190821 |