FDA.reportPublic FDA data

NDC 59115-070-09 - 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
59115-070
Requested NDC
59115-070-09
Package NDCs from labels
59115-070-01, 59115-070-09, 59115-070-30
Manufacturer
Hikma Pharmaceutical
Effective date
2019-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Modafinil - Hikma PharmaceuticalHikma Pharmaceutical2019-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMODAFINIL TABLET [HIKMA PHARMACEUTICAL]5

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 1 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ModafinilMODAFINILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1a309416-bd6a-45b1-982f-b689b097453d2026-09-03Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
ModafinilMODAFINILApotex Corp.944daf47-49a6-93ca-e348-4a0f1b6d937e2026-07-21Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
ModafinilMODAFINILPreferred Pharmaceuticals Inc.60ec6e2a-2576-498f-9a8c-fddc53d4a44c2026-07-17Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
ModafinilMODAFINILPreferred Pharmaceuticals Inc.013450dd-cd42-46c7-98d6-9a29257619782026-07-14Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ModafinilMODAFINILGolden State Medical Supply, Inc.1d4c6858-5b2f-f216-e063-6394a90aad5d2026-03-16Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4c9c4e61-517c-a9d2-e063-6394a90a58c72026-03-09Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4aa3bdad-163f-fda1-e063-6394a90ae1d82026-02-12Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
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
unii: R3UK8X3U3D
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
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
unii: R3UK8X3U3D
ProvigilMODAFINILGolden State Medical Supply, Inc.3b8d1c32-dac9-50e6-e063-6394a90aa5a52025-10-16Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
ProvigilMODAFINILApotex Corp0391f182-1958-9fef-a944-53b229ce99e72025-08-27Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
ModafinilMODAFINILMajor Pharmaceuticals4a7ab52b-db31-4774-a06a-b11f2bb606622025-03-11Warnings, Adverse reactionsExact identifier
unii: R3UK8X3U3D

Reported adverse events (FAERS/openFDA)#

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