FDA.reportPublic FDA data

Nuvigil

Product NDC
63459-225
11-digit product format
634590225
Labeler code
63459
Product ID
63459-225_a70488d7-57ea-446e-89c2-87b0ecc90023
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
2026-06-30
Substance
ARMODAFINIL
Active strength
250 mg/1
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nuvigil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV63XWA605I
Rxcui724859, 724861, 724863, 805659, 805661, 805663, 861960, 861962

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
63459-225-07Nuvigil7 in 1 BLISTER PACKTABLET732
63459-225-30Nuvigil30 in 1 BOTTLETABLET3032
63459-225-35Nuvigil5 in 1 CARTONTABLET532

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-225NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC]32Current NDC, Legacy NDC, 3 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
724859armodafinil 150 MG Oral TabletPSN795a7ba3-c60b-4637-aa99-06c1e10af8a72
724861armodafinil 250 MG Oral TabletPSN795a7ba3-c60b-4637-aa99-06c1e10af8a72
805659Nuvigil 150 MG Oral TabletPSN795a7ba3-c60b-4637-aa99-06c1e10af8a72
805661NUVIGIL 250 MG Oral TabletPSN795a7ba3-c60b-4637-aa99-06c1e10af8a72
805659armodafinil 150 MG Oral Tablet [Nuvigil]SBD795a7ba3-c60b-4637-aa99-06c1e10af8a72
805661armodafinil 250 MG Oral Tablet [Nuvigil]SBD795a7ba3-c60b-4637-aa99-06c1e10af8a72
724859armodafinil 150 MG Oral TabletSCD795a7ba3-c60b-4637-aa99-06c1e10af8a72
724861armodafinil 250 MG Oral TabletSCD795a7ba3-c60b-4637-aa99-06c1e10af8a72
805659Nuvigil 150 MG Oral TabletSY795a7ba3-c60b-4637-aa99-06c1e10af8a72
805661Nuvigil 250 MG Oral TabletSY795a7ba3-c60b-4637-aa99-06c1e10af8a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63459-225-07634590225077 in 1 BLISTER PACKHistorical
63459-225-306345902253030 TABLET in 1 BOTTLE (63459-225-30) 30 tablet2011-01-032026-06-30NoNoCurrent
63459-225-35634590225355 BLISTER PACK in 1 CARTON (63459-225-35) > 7 TABLET in 1 BLISTER PACK (63459-225-07) 5 blister pack2009-05-260000-00-00NoNoCurrent