FDA.reportPublic FDA data

NDC 68382-477-30 - Pramipexole Dihydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68382-477
Requested NDC
68382-477-30
Package NDCs from labels
68382-477-06, 68382-477-30, 68382-477-77
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2022-11-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAMIPEXOLE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2022-11-10HUMAN PRESCRIPTION DRUG LABEL

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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEA-S Medication Solutions29b639e3-25a5-4c2f-b4ea-a119db79fe0c2026-09-09Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack468830df-941c-4363-b432-94de9b7fd2ac2026-06-29Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 2KR89I4H1Y
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
unii: ZF94AP8MEY
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack46f88017-7b0e-437e-90b1-37bdf9013e722026-05-22Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack7a5d1b22-179a-44ae-9545-2704414b99052026-05-15Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackf1ff3695-33db-471d-a3db-89fbb9ed9e0c2026-05-14Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 2KR89I4H1Y
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEA-S Medication Solutions3db0613d-524b-4b33-9a07-602f84d6c3042026-04-26Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack422b27af-5e7d-4fe1-81bc-ed545c26b4762026-04-17Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad2026-04-07Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackbd0f7ae1-11ef-4fab-894f-c4c59f75aa992026-04-03Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackdd4b4e2a-97b5-417d-bb90-bec692dc359b2026-04-02Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDETorrent Pharmaceuticals Limited60167d7c-469f-455a-a113-561841af5e592026-03-31Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAmerican Health Packagingf4d97c2e-f447-4cfe-b9d4-852323f0cfb52026-03-03Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: O7TSZ97GEP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.