FDA.reportPublic FDA data

NDC 0378-5575-01 - Modafinil

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
0378-5575
Requested NDC
0378-5575-01
Package NDCs from labels
0378-5575-93, 0378-5575-05, 0378-5575-01
Manufacturer
Mylan Institutional Inc.
Effective date
2019-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Modafinil - Mylan Institutional Inc.Mylan Institutional Inc.2019-11-07HUMAN PRESCRIPTION DRUG LABEL
Modafinil - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2019-10-31HUMAN PRESCRIPTION DRUG LABEL
Modafinil - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2016-03-17HUMAN PRESCRIPTION DRUG LABEL
Modafinil - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2014-04-03HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5575-01EA - Each0378-5575c1aa9f9a-3b66-4f85-a554-b2a0ea9a339912013-02-13
0378-5575-05EA - Each0378-5575f12cf010-198e-40b0-b820-3eab9c75c67812013-02-13
0378-5575-93EA - Each0378-5575e79ed0aa-9321-4f3a-b19a-6a10905d27f012013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]7
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]3
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]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 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC463bb960-a0b5-4ca4-e063-6294a90a683b2025-12-18Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
ModafinilMODAFINILGolden State Medical Supply, Inc.457662d8-b95c-d3af-e063-6294a90a883e2025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
ProvigilMODAFINILGolden State Medical Supply, Inc.3b8d1c32-dac9-50e6-e063-6394a90aa5a52025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
ProvigilMODAFINILApotex Corp0391f182-1958-9fef-a944-53b229ce99e72025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltdc277f1d8-2ee0-4111-adb6-38998f77dede2025-07-18WarningsExact identifier
unii: L11K75P92J
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltd81d59754-1b36-4f71-aec1-5335b003a96f2025-07-01WarningsExact identifier
unii: L11K75P92J
ModafinilMODAFINILMajor Pharmaceuticals4a7ab52b-db31-4774-a06a-b11f2bb606622025-03-11Warnings, Adverse reactionsExact identifier
rxcui: 205324
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
ModafinilMODAFINILAmerican Health Packaging928a3ab6-b53c-4924-882c-9f2f49aba0f12024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 205324
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

Reported adverse events (FAERS/openFDA)#

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