NDC 68382-474-30 - 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
68382-474
Requested NDC
68382-474-30
Package NDCs from labels
68382-474-06, 68382-474-30, 68382-474-77
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 4 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: ZF94AP8MEY
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Limitedb6935240-ee81-49ef-adad-fb900d7f51272023-01-27Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEDr. Reddy's Laboratories Limited00699692-532a-68fd-8a51-3770a81b22082021-08-31Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole Dihydrochloride Extended-ReleasePRAMIPEXOLE DIHYDROCHLORIDEXiamen LP Pharmaceutical Co., Ltd.1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c2021-06-16Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Limited92f6ef1e-3256-45a7-a409-80dd85e951872017-11-20Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 2KR89I4H1Y
PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.a7405a56-de1c-4875-b57f-210c991474ba2016-10-13Warnings, Adverse reactionsExact identifier
unii: 3D867NP06J

Reported adverse events (FAERS/openFDA)#

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