FDA.reportPublic FDA data

pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet

RxCUI
901550
RxNorm name
pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet
Display name
pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet
Full name
pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet
Term type
SY
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 · 6 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: 901550
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDENorthStar RxLLC946c8a72-8c48-4925-93d3-7940f4c0fd292024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 901550
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEMacleods Pharmaceuticals Limited1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be2024-07-06Warnings, Adverse reactionsExact identifier
rxcui: 901550
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Inc.e18b67b6-a085-43e5-bb2b-fe74fa00cb652024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 901550
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Limitedb6935240-ee81-49ef-adad-fb900d7f51272023-01-27Warnings, Adverse reactionsExact identifier
rxcui: 901550
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEDr. Reddy's Laboratories Limited00699692-532a-68fd-8a51-3770a81b22082021-08-31Warnings, Adverse reactionsExact identifier
rxcui: 901550

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
00699692-532a-68fd-8a51-3770a81b2208pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 1.5 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 1.5 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 1.5 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 1.5 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 1.5 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 1.5 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 1.5 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
1d2b1d2c-ae22-424a-bad7-ce24a817b042pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 1.5 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 1.5 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet [SCD] · pramipexole dihydrochloride 1.5 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