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 2 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: L11K75P92J
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: L11K75P92J
Rib Cage Pain Drops 2056RIB CAGE PAIN DROPSProfessional Complementary Health Formulasf8051769-9714-4444-b736-04b95af64a9b2026-01-08WarningsExact identifier
unii: L11K75P92J
Seventh Chakra (Crown) 7307SEVENTH CHAKRA (CROWN)Professional Complementary Health Formulas06a2e818-ce9a-4930-adef-5b9990f1b8a32026-01-08WarningsExact identifier
unii: L11K75P92J
Memory Drops 2043MEMORY DROPSProfessional Complementary Health Formulasa9b8897b-e5a1-4db3-94dd-8012aded6ed72026-01-08WarningsExact identifier
unii: L11K75P92J
ModafinilMODAFINILAvPAK4790bbe9-d753-1067-02ee-9536011650d92026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
Calcarea Phosphorica 8002CALCAREA PHOSPHORICAProfessional Complementary Health Formulas555dd940-ed07-4160-bae3-1b4d320dec662026-01-08WarningsExact identifier
unii: L11K75P92J
Calcarea Combination 9214CALCAREA COMBINATIONProfessional Complementary Health Formulas54b605d6-1e58-41b1-865b-1280ed75d4942026-01-08WarningsExact identifier
unii: L11K75P92J
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: L11K75P92J
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: L11K75P92J
Lactation Flow Drops 2149LACTATION FLOW DROPSProfessional Complementary Health Formulas66a063c4-aa38-4c8e-b361-ee841165edeb2026-01-08WarningsExact identifier
unii: L11K75P92J
Nocturnal Enuresis Drops 2011NOCTURNAL ENURESIS DROPSProfessional Complementary Health Formulas9cd29086-c9eb-4db1-a219-2a8bae3663d82026-01-08WarningsExact identifier
unii: L11K75P92J
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: L11K75P92J
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: L11K75P92J
Myosotis Combination 9234MYOSOTIS COMBINATIONProfessional Complementary Health Formulas8cc292dc-b959-4d81-8277-03044992fccb2026-01-08WarningsExact identifier
unii: L11K75P92J
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: L11K75P92J
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: L11K75P92J
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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