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 3 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: FZ989GH94E
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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