FDA.reportPublic FDA data

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

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEIngenus Pharmaceuticals, LLC1d2b1d2c-ae22-424a-bad7-ce24a817b0422025-04-24Warnings, Adverse reactionsExact identifier
rxcui: 901541
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDENorthStar RxLLC946c8a72-8c48-4925-93d3-7940f4c0fd292024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 901541
Pramipexole Dihydrochloride Extended-ReleasePRAMIPEXOLE DIHYDROCHLORIDEVitruvias Therapeutics, Inc.d07aad1b-e078-4fca-8386-ca2e8e8996882024-07-23Warnings, Adverse reactionsExact identifier
rxcui: 901541
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEMacleods Pharmaceuticals Limited1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be2024-07-06Warnings, Adverse reactionsExact identifier
rxcui: 901541
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Inc.e18b67b6-a085-43e5-bb2b-fe74fa00cb652024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 901541
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Limitedb6935240-ee81-49ef-adad-fb900d7f51272023-01-27Warnings, Adverse reactionsExact identifier
rxcui: 901541
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEDr. Reddy's Laboratories Limited00699692-532a-68fd-8a51-3770a81b22082021-08-31Warnings, Adverse reactionsExact identifier
rxcui: 901541
Pramipexole Dihydrochloride Extended-ReleasePRAMIPEXOLE DIHYDROCHLORIDEXiamen LP Pharmaceutical Co., Ltd.1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c2021-06-16Warnings, Adverse reactionsExact identifier
rxcui: 901541

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
00699692-532a-68fd-8a51-3770a81b2208pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]316These 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: 199720210831
e18b67b6-a085-43e5-bb2b-fe74fa00cb65pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]313These 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: 199720240620
1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7bepramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]38These 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: 199720240706
946c8a72-8c48-4925-93d3-7940f4c0fd29pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]36These 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: 199720240820
d07aad1b-e078-4fca-8386-ca2e8e899688pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]34These 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: 199720240723
1d2b1d2c-ae22-424a-bad7-ce24a817b042pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]32These 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: 199720250424
b6935240-ee81-49ef-adad-fb900d7f5127pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]32These 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: 199720230127
1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3cpramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet [SY]31These 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: 199720210616