FDA.reportPublic FDA data

NDC 65862-604-10 - 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
65862-604
Requested NDC
65862-604-10
Package NDCs from labels
65862-604-90, 65862-604-99, 65862-604-10, 65862-604-78
Manufacturer
Aurobindo Pharma Limited
Effective date
2025-10-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pramipexole Dihydrochloride - Aurobindo Pharma LimitedAurobindo Pharma Limited2025-10-03Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-604-10Pramipexole Dihydrochloride10 in 1 BLISTER PACKTABLET1015
65862-604-78Pramipexole Dihydrochloride10 in 1 CARTONTABLET1015
65862-604-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9015
65862-604-99Pramipexole Dihydrochloride1000 in 1 BOTTLETABLET100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-604PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 4 package rows20240218_3f90971a-e005-4dd3-bb93-b09125ada3c8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-604-90EA - Each65862-60472c1ee3e-a7b7-47ae-94b1-5ded61d53e9c12013-09-04
65862-604-99EA - Each65862-604609f62e7-d972-4ed7-bcb6-ba22fc05745212013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4

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 25 of 32 · 629 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.22c8f143-1c23-4a10-9577-2adc03f1b6b22023-12-28WarningsExact identifier
unii: ETJ7Z6XBU4
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEA-S Medication Solutions7cd6a546-d516-427c-af79-555390ccd35b2023-12-15Warnings, Adverse reactionsExact identifier
application number: ANDA202633
rxcui: 859048
unii: 3D867NP06J
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Limited0a3ed933-ef5b-4091-8ae9-5768ae18514f2023-12-08Warnings, Adverse reactionsExact identifier
rxcui: 859052
rxcui: 859048
rxcui: 859044
rxcui: 859033
rxcui: 859040
unii: 3D867NP06J
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Silica marinaSILICON DIOXIDEBoiron81442e86-bef4-4992-e053-2a91aa0a24532023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d2b8f2-dce0-c136-e053-2991aa0a0fdb2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d31d98-dd71-870e-e053-2991aa0a0ce72023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3ffad-5be4-700a-e053-2991aa0a1cc92023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3206e-a893-3f0c-e053-2991aa0a149f2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3d6ca-8b63-2e63-e053-2991aa0a0e052023-11-15Exact identifier
unii: ETJ7Z6XBU4
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c31d465-caac-3a02-e053-2a95a90adb3b2023-11-03WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus SarcodeECHINACEA PURPUREA, MYRISTICA SEBIFERA, BELLADONNA, CALCAREA SULPHURICA, THYMUS (OVINE), ARSENICUM ALBUM, SILICEA, SULPHUR IODATUM, CALCAREA FLUORICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUSNutritional Specialties, Inc.2dfda48f-5795-4b98-8bb2-bf65273e89202023-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect skin protectantALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltd84a86989-bb7c-4f96-8cc0-d676264845322023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect acid indigestion and heartburn reliefALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, MAGNESIA MURIATICA, NATRUM NITRICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUMKadesh Incoporation Co,Ltd048367ff-a9bb-46a3-a835-aa3ab391eee42023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect hangover reliefALUMINA SILICATA, CALCAREA SILICATA, SILICEA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, FERRUM MURIATICUM, SULPHUR, PHOSPHORUSKadesh Incoporation Co,Ltdc9821e87-1e8d-48ab-8821-32e7e660309a2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect first aid antiseptic and antibiotic solutionSILICEA, SULPHUR, PHOSPHORUS, CALCAREA SILICATA, NATRUM NITRICUM, FERRUM MURIATICUM, KALI SILICATUMKadesh Incoporation Co,Ltd9bd266bb-7078-413f-8fc9-6423535891302023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect cold remedyCALCAREA FLOURICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, SILICEA, SULPHUR, ZINCUM METALLICUMKadesh Incoporation Co,Ltd14d2a1fe-a1f1-4e85-96c0-d8b90260336c2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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