pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet
- RxCUI
- 901541
- RxNorm name
- pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet
- Display name
- pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet
- Full name
- pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:38:45
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 |
|---|---|---|---|---|---|---|
| Pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 1d2b1d2c-ae22-424a-bad7-ce24a817b042 | 2025-04-24 | Warnings, Adverse reactions | 901541 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | NorthStar RxLLC | 946c8a72-8c48-4925-93d3-7940f4c0fd29 | 2024-08-20 | Warnings, Adverse reactions | 901541 |
| Pramipexole Dihydrochloride Extended-Release | PRAMIPEXOLE DIHYDROCHLORIDE | Vitruvias Therapeutics, Inc. | d07aad1b-e078-4fca-8386-ca2e8e899688 | 2024-07-23 | Warnings, Adverse reactions | 901541 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Macleods Pharmaceuticals Limited | 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be | 2024-07-06 | Warnings, Adverse reactions | 901541 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Inc. | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 2024-06-20 | Warnings, Adverse reactions | 901541 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Limited | b6935240-ee81-49ef-adad-fb900d7f5127 | 2023-01-27 | Warnings, Adverse reactions | 901541 |
| Pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Dr. Reddy's Laboratories Limited | 00699692-532a-68fd-8a51-3770a81b2208 | 2021-08-31 | Warnings, Adverse reactions | 901541 |
| Pramipexole Dihydrochloride Extended-Release | PRAMIPEXOLE DIHYDROCHLORIDE | Xiamen LP Pharmaceutical Co., Ltd. | 1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c | 2021-06-16 | Warnings, Adverse reactions | 901541 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 00699692-532a-68fd-8a51-3770a81b2208 | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 16 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE dihydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20210831 |
| 00699692-532a-68fd-8a51-3770a81b2208 | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 16 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE dihydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20210831 |
| 00699692-532a-68fd-8a51-3770a81b2208 | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 16 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE dihydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20210831 |
| e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 13 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240620 |
| e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 13 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240620 |
| e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 13 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240620 |
| 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 8 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240706 |
| 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 8 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240706 |
| 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 8 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240706 |
| 946c8a72-8c48-4925-93d3-7940f4c0fd29 | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 6 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240820 |
| 946c8a72-8c48-4925-93d3-7940f4c0fd29 | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 6 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240820 |
| 946c8a72-8c48-4925-93d3-7940f4c0fd29 | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 6 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240820 |
| d07aad1b-e078-4fca-8386-ca2e8e899688 | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 4 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240723 |
| d07aad1b-e078-4fca-8386-ca2e8e899688 | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 4 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240723 |
| d07aad1b-e078-4fca-8386-ca2e8e899688 | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 4 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20240723 |
| 1d2b1d2c-ae22-424a-bad7-ce24a817b042 | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 2 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20250424 |
| 1d2b1d2c-ae22-424a-bad7-ce24a817b042 | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 2 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20250424 |
| 1d2b1d2c-ae22-424a-bad7-ce24a817b042 | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 2 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20250424 |
| b6935240-ee81-49ef-adad-fb900d7f5127 | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 2 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20230127 |
| b6935240-ee81-49ef-adad-fb900d7f5127 | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 2 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20230127 |
| b6935240-ee81-49ef-adad-fb900d7f5127 | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 2 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20230127 |
| 1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | 1 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20210616 |
| 1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | 1 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20210616 |
| 1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | 1 | These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997 | 20210616 |