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 4 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dairy-Grain-NightshadeIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.99fcbd61-ecc8-cf9d-e053-2995a90aebeb2025-07-25WarningsExact identifier
unii: J2B2A4N98G
ModafinilMODAFINILMajor Pharmaceuticals4a7ab52b-db31-4774-a06a-b11f2bb606622025-03-11Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC2bc3cd03-2726-f693-e063-6294a90a7a032025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Dairy-Grain-NightshadesIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
unii: J2B2A4N98G
ModafinilMODAFINILAmerican Health Packaging928a3ab6-b53c-4924-882c-9f2f49aba0f12024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
ModafinilMODAFINILBryant Ranch Prepack3f733d7f-1213-4534-9433-0eb99a5abc2c2024-09-23Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,Deseret Biologicals, Inc.e03d8463-287a-4509-a9f4-0ad38a98377c2024-09-11WarningsExact identifier
unii: J2B2A4N98G
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCIUM CITRATE, CALCIUM GLUCONATE, CARBO VEGETABILIS, CHAMOMILLA, CHOLINUM, CINNAMIC ACID, COUMARINUM, EUGENOL, FOLIC ACID, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), GAERTNER BACILLUS (BACH), HISTAMINUM HYDROCHLORICUM, ILEUM (SUIS), JEJUNUM (SUIS), L-ASPARAGINE (MONOHYDRATE), LAC CANINUM, LAC DEFLORATUM, LAC FELINUM, LAC HUMANUM, LAC VACCINUM, MENADIONE,Deseret Biologicals, Inc.e2bc26d2-1719-40c5-a6f9-8ff1f364c3cf2024-09-06WarningsExact identifier
unii: J2B2A4N98G
ModafinilMODAFINILBryant Ranch Prepack963aa6be-5aed-4865-b375-8c2c3102e7bc2024-08-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILZydus Lifesciences Limitedf39820fb-8248-4d42-854c-6fe2d9b92d362024-08-16Exact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackf1ff7c6d-df04-48dd-a971-454d38e7d9972024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackf0c43046-fc86-4b62-bd0f-704a6894625d2024-07-08Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILProficient Rx LPc332ea93-48d9-4c8a-a1ef-01c27a61350b2024-07-01Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILNuCare Pharmaceuticals,Inc.98e54b10-8ae0-7c43-e053-2a95a90ae8bb2024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 260218
unii: R3UK8X3U3D
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
ModafinilMODAFINILRising Pharma Holdings, Inc.4b63aac6-4385-44a3-8390-cdbb0b4b5fe02024-05-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAurobindo Pharma Limitedf51ca007-3955-4540-a88a-0ddae8d8e8ab2024-05-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D

Reported adverse events (FAERS/openFDA)#

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