FDA.reportPublic FDA data

Nuvigil

Product NDC
63459-205
11-digit product format
634590205
Labeler code
63459
Product ID
63459-205_a91bc1a1-b6c3-4d20-962c-fa5492af491c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Cephalon, LLC
Application
NDA021875
Marketing category
NDA
Marketing start
2009-05-26
Marketing end
0000-00-00
Substance
ARMODAFINIL
Active strength
50 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf31ebd7-fd9d-472c-88e1-94944f023ec0Product name320190628

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-205-30Nuvigil30 in 1 BOTTLETABLET3032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-205-30EA - Each63459-20511c3f3fb-d986-413e-af8c-79c7c11cd0c812012-07-24
63459-205-60EA - Each63459-205c66b1cdf-83b9-4b48-bcad-b9a85a010bc412012-07-24

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 [REBEL DISTRIBUTORS CORP]1
armodafinilACTIVE MOIETYV63XWA605INUVIGIL (ARMODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-205NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC]32Legacy NDC, 1 package rows20250507_d878aed0-ddbf-8fa1-abf7-d3e480260845.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
861960armodafinil 200 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
724861armodafinil 250 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
724863armodafinil 50 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
805659Nuvigil 150 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
861962Nuvigil 200 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
805661NUVIGIL 250 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
805663NUVIGIL 50 MG Oral TabletPSNd878aed0-ddbf-8fa1-abf7-d3e48026084532
805659armodafinil 150 MG Oral Tablet [Nuvigil]SBDd878aed0-ddbf-8fa1-abf7-d3e48026084532
861962armodafinil 200 MG Oral Tablet [Nuvigil]SBDd878aed0-ddbf-8fa1-abf7-d3e48026084532
805661armodafinil 250 MG Oral Tablet [Nuvigil]SBDd878aed0-ddbf-8fa1-abf7-d3e48026084532
805663armodafinil 50 MG Oral Tablet [Nuvigil]SBDd878aed0-ddbf-8fa1-abf7-d3e48026084532
724859armodafinil 150 MG Oral TabletSCDd878aed0-ddbf-8fa1-abf7-d3e48026084532
861960armodafinil 200 MG Oral TabletSCDd878aed0-ddbf-8fa1-abf7-d3e48026084532
724861armodafinil 250 MG Oral TabletSCDd878aed0-ddbf-8fa1-abf7-d3e48026084532
724863armodafinil 50 MG Oral TabletSCDd878aed0-ddbf-8fa1-abf7-d3e48026084532
805659Nuvigil 150 MG Oral TabletSYd878aed0-ddbf-8fa1-abf7-d3e48026084532
861962Nuvigil 200 MG Oral TabletSYd878aed0-ddbf-8fa1-abf7-d3e48026084532
805661Nuvigil 250 MG Oral TabletSYd878aed0-ddbf-8fa1-abf7-d3e48026084532
805663Nuvigil 50 MG Oral TabletSYd878aed0-ddbf-8fa1-abf7-d3e48026084532
724863armodafinil 50 MG Oral TabletPSN10f918f7-4782-470e-a50e-35c7c66bfd791
805663NUVIGIL 50 MG Oral TabletPSN10f918f7-4782-470e-a50e-35c7c66bfd791
805663armodafinil 50 MG Oral Tablet [Nuvigil]SBD10f918f7-4782-470e-a50e-35c7c66bfd791
724863armodafinil 50 MG Oral TabletSCD10f918f7-4782-470e-a50e-35c7c66bfd791
805663Nuvigil 50 MG Oral TabletSY10f918f7-4782-470e-a50e-35c7c66bfd791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63459-205-306345902053030 TABLET in 1 BOTTLE (63459-205-30) 30 tablet2011-01-030000-00-00NoNoCurrent
63459-205-996345902059980000 TABLET in 1 DRUM (63459-205-99)80000 tablet26-MAY-09Current