FDA.reportPublic FDA data

pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet

RxCUI
858625
RxNorm name
pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet
Display name
pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet
Full name
pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDETorrent Pharmaceuticals Limited60167d7c-469f-455a-a113-561841af5e592026-03-31Warnings, Adverse reactionsExact identifier
rxcui: 858625
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEGolden State Medical Supply, Inc.f8ac759f-59fb-49e4-a772-4114facdaea32026-01-26Warnings, Adverse reactionsExact identifier
rxcui: 858625
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA44c336d2-01d1-4f13-bad9-549cdc3505ec2025-12-30Warnings, Adverse reactionsExact identifier
rxcui: 858625
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEScieGen Pharmaceuticals Inc395fee34-43dc-4840-a6b8-70d5736f9c8b2025-12-24Warnings, Adverse reactionsExact identifier
rxcui: 858625
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDERising Pharma Holdings, Inc.56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec2025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 858625
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack794fdab8-1c15-4469-963e-4f9e3495536f2025-11-17Warnings, Adverse reactionsExact identifier
rxcui: 858625
pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.b978aa75-c62d-444b-9ec6-6c0d21a666882025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 858625
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAurobindo Pharma Limited3f90971a-e005-4dd3-bb93-b09125ada3c82025-10-03Warnings, Adverse reactionsExact identifier
rxcui: 858625
pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEStrides Pharma Science Limitedfb2260d6-204c-4d25-a331-0f8340d83a6e2025-08-01Warnings, Adverse reactionsExact identifier
rxcui: 858625
PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.a7405a56-de1c-4875-b57f-210c991474ba2016-10-13Warnings, Adverse reactionsExact identifier
rxcui: 858625

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 11 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
794fdab8-1c15-4469-963e-4f9e3495536fpramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]3100These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720251117
60167d7c-469f-455a-a113-561841af5e59pramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]322These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720260331
f8ac759f-59fb-49e4-a772-4114facdaea3pramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]315PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720260126
3f90971a-e005-4dd3-bb93-b09125ada3c8pramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]315These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720251003
395fee34-43dc-4840-a6b8-70d5736f9c8bpramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]314These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720251224
44c336d2-01d1-4f13-bad9-549cdc3505ecpramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]313These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720251230
b978aa75-c62d-444b-9ec6-6c0d21a66688pramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]312These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720251014
56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ecpramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]311These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720251211
fb2260d6-204c-4d25-a331-0f8340d83a6epramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]310These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720211007
2cc30954-ba71-4313-bd69-b718da254b5apramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]37These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199720180808
a7405a56-de1c-4875-b57f-210c991474bapramipexole dihydrochloride 0.75 MG Oral Tablet [PSN] · pramipexole dihydrochloride 0.75 MG Oral Tablet [SCD] · pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet [SY]34PRAMIPEXOLE DIHYDROCHLORIDE Tablets Rx Only HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE tablets safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE tablets. PRAMIPEXOLE DIHYDROCHLORIDE tablets for oral use Initial U.S. Approval: 199720161013