FDA.reportPublic FDA data

Nuvigil

Product NDC
63459-225
Requested package NDC
63459-225-30
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
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63459-22563459-225-30DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021875-001NUVIGILARMODAFINIL50MGTABLET / ORALABRLD2007-06-15
N021875-002NUVIGILARMODAFINIL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-03-26
N021875-003NUVIGILARMODAFINIL150MGTABLET / ORALABRLD2007-06-15
N021875-004NUVIGILARMODAFINIL250MGTABLET / ORALABRLD, RS2007-06-15
N021875-005NUVIGILARMODAFINIL200MGTABLET / ORALABRLD2009-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021875-001AB
N021875-003AB
N021875-004AB
N021875-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021875-001NUVIGIL50MGTABLET / ORALABRLD2007-06-15a50c72e98297…
2026-08-01 22:54:322026-06N021875-002NUVIGIL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-03-26a50c72e98297…
2026-08-01 22:54:322026-06N021875-003NUVIGIL150MGTABLET / ORALABRLD2007-06-15a50c72e98297…
2026-08-01 22:54:322026-06N021875-004NUVIGIL250MGTABLET / ORALABRLD, RS2007-06-15a50c72e98297…
2026-08-01 22:54:322026-06N021875-005NUVIGIL200MGTABLET / ORALABRLD2009-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021875-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021875-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021875-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N021875-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuvigilARMODAFINILGolden State Medical Supply, Inc.3dd49302-f757-d945-e063-6294a90afcba2025-09-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
NuvigilARMODAFINILApotex Corp.a69631d0-1263-769e-b232-4ab9160e0fa32025-08-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ARMODAFINILARMODAFINILDirectRxddd06dab-0855-5b4e-e053-2a95a90a5e672025-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ARMODAFINILARMODAFINILdirect rxb1ba1cdd-cf57-7a8c-e053-2a95a90a2c192025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ArmodafinilARMODAFINILQuality Care Products LLC98338994-7818-4b86-ae98-cd08fa7008792024-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ArmodafinilARMODAFINILTeva Pharmaceuticals USA, Inc.b3cac300-c3d2-4189-a410-2aaf3773c0902023-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ArmodafinilARMODAFINILSandoz Inca3341ec8-1ad4-49e2-922b-13d1b30c8c1d2023-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
NuvigilARMODAFINILCephalon, LLCd878aed0-ddbf-8fa1-abf7-d3e4802608452022-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ndc (package): 63459-225-30
ndc (product): 63459-225
ndc11 (package): 63459022530

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL250 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
63459-225-07Nuvigil7 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
63459-225-306345902253030 TABLET in 1 BOTTLE (63459-225-30) 30 tablet2011-01-032026-06-30NoNoCurrent