FDA.reportPublic FDA data

NDC 63459-0201 - PROVIGIL

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
63459-0201
Manufacturer
Rebel Distributors Corp
Effective date
2010-12-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROVIGIL - Rebel Distributors CorpRebel Distributors Corp2010-12-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
MODAFINILACTIVE MOIETYR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1

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 2 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4c9c4e61-517c-a9d2-e063-6394a90a58c72026-03-09Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4aa3bdad-163f-fda1-e063-6394a90ae1d82026-02-12Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
ModafinilMODAFINILAvPAK4790bbe9-d753-1067-02ee-9536011650d92026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: J2B2A4N98G
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: FZ989GH94E
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
unii: FZ989GH94E
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
unii: FZ989GH94E
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
unii: FZ989GH94E
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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