FDA.reportPublic FDA data

NDC 63459-220-07 - Nuvigil

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
63459-220
Requested NDC
63459-220-07
Package NDCs from labels
63459-220-07, 63459-220-35, 63459-220-30
Manufacturer
Cephalon, LLC
Effective date
2022-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nuvigil - Cephalon, LLCCephalon, LLC2022-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-220-07Nuvigil7 in 1 BLISTER PACKTABLET732
63459-220-30Nuvigil30 in 1 BOTTLETABLET3032
63459-220-35Nuvigil5 in 1 CARTONTABLET532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-220NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC]32Legacy NDC, 3 package rows20250507_d878aed0-ddbf-8fa1-abf7-d3e480260845.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARMODAFINILACTIVE INGREDIENTV63XWA605INUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16
ARMODAFINILACTIVE MOIETYV63XWA605INUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQNUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]16

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ArmodafinilARMODAFINILPreferred Pharmaceuticals Inc.93b9f9a4-66d9-4ed9-8f2f-903e416e900d2026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILPreferred Pharmaceuticals Inc.4128759d-ed7c-4130-b24c-a0541f2b9e7f2026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 724859
unii: V63XWA605I
ArmodafinilARMODAFINILBryant Ranch Prepack58e33a21-7816-4fa9-9fc7-c559426ad2b92026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 724859
unii: V63XWA605I
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
NuvigilARMODAFINILGolden State Medical Supply, Inc.3dd49302-f757-d945-e063-6294a90afcba2025-09-02Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861962
rxcui: 861960
rxcui: 805661
rxcui: 805659
rxcui: 805663
unii: V63XWA605I
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
ARMODAFINILARMODAFINILDirectRxddd06dab-0855-5b4e-e053-2a95a90a5e672025-01-22Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILDirect_Rxfacd329b-1925-61df-e053-6294a90ab7382025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 724863
unii: V63XWA605I
ARMODAFINILARMODAFINILdirect rxb1ba1cdd-cf57-7a8c-e053-2a95a90a2c192025-01-20Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724861
unii: V63XWA605I
ArmodafinilARMODAFINILQuality Care Products LLC98338994-7818-4b86-ae98-cd08fa7008792024-12-17Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724861
unii: V63XWA605I
ArmodafinilARMODAFINILBryant Ranch Prepackcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 724859
rxcui: 724861
unii: V63XWA605I
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ArmodafinilARMODAFINILAurobindo Pharma Limited23da56b8-7552-4362-a1ab-e794c131194c2024-02-02Warnings, Adverse reactionsExact identifier
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILNatco Pharma USA LLCde2f0921-e791-426c-9192-2b7162e2158c2023-12-05Warnings, Adverse reactionsExact identifier
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILTeva Pharmaceuticals USA, Inc.b3cac300-c3d2-4189-a410-2aaf3773c0902023-01-31Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILSandoz Inca3341ec8-1ad4-49e2-922b-13d1b30c8c1d2023-01-31Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I
NuvigilARMODAFINILCephalon, LLCd878aed0-ddbf-8fa1-abf7-d3e4802608452022-12-31Warnings, Adverse reactionsExact identifier
application number: NDA021875
ndc (package): 63459-220-07
ndc (package): 63459-215-30
ndc (package): 63459-225-35
ndc (package): 63459-225-30
ndc (package): 63459-225-07
ndc (package): 63459-215-07
ndc (package): 63459-220-30
ndc (package): 63459-215-35
ndc (package): 63459-205-30
ndc (package): 63459-220-35
ndc (product): 63459-225
ndc (product): 63459-220
ndc (product): 63459-205
ndc (product): 63459-215
ndc11 (package): 63459022007
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861962
rxcui: 861960
rxcui: 805661
rxcui: 805659
rxcui: 805663
spl id: a70488d7-57ea-446e-89c2-87b0ecc90023
spl set id: d878aed0-ddbf-8fa1-abf7-d3e480260845
unii: V63XWA605I

Reported adverse events (FAERS/openFDA)#

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