FDA.reportPublic FDA data

NDC 63459-225-07 - 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
63459-225
Requested NDC
63459-225-07
Package NDCs from labels
63459-225-07, 63459-225-35, 63459-225-30
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
NUVIGIL ® (armodafinil) Tablets [C-IV]STAT Rx USA LLC | PSS World Medical Inc.2012-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-225-07Nuvigil7 in 1 BLISTER PACKTABLET732
63459-225-30Nuvigil30 in 1 BOTTLETABLET3032
63459-225-35Nuvigil5 in 1 CARTONTABLET532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-225NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC]32Legacy NDC, 3 package rows20250507_d878aed0-ddbf-8fa1-abf7-d3e480260845.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-225-30EA - Each63459-225237e3089-bdcf-444a-8422-a268d8abfa4012012-07-24
63459-225-60EA - Each63459-2252259ae96-4c72-446f-9796-ecac197c58c312012-07-24

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
ARMODAFINILACTIVE INGREDIENTV63XWA605INUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2
ARMODAFINILACTIVE MOIETYV63XWA605INUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]2

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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArmodafinilARMODAFINILMylan Pharmaceuticals Inc.de0799f7-7644-4057-a7da-75436f978c612018-09-17Warnings, Adverse reactionsExact identifier
rxcui: 724863
rxcui: 724859
rxcui: 724861
unii: V63XWA605I
8bb2ff27-f4a9-468f-bb6f-4a6635bdbead795a7ba3-c60b-4637-aa99-06c1e10af8a72012-10-08Warnings, Adverse reactionsExact identifier
spl id: 8bb2ff27-f4a9-468f-bb6f-4a6635bdbead
spl set id: 795a7ba3-c60b-4637-aa99-06c1e10af8a7

Reported adverse events (FAERS/openFDA)#

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