FDA.reportPublic FDA data

Nuvigil

Product NDC
63459-215
Requested package NDC
63459-215-35
11-digit product format
634590215
Labeler code
63459
Product ID
63459-215_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
2028-06-30
Substance
ARMODAFINIL
Active strength
150 mg/1
DEA schedule
CIV
NDC exclude flag
No
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 packagepackage63459-21563459-215-35DDiscontinued 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N021875-002NUVIGILARMODAFINIL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-03-26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): 63459-215-35
ndc (product): 63459-215
ndc11 (package): 63459021535

Additional Listing Data#

Finished product
Yes
Brand name base
Nuvigil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V63XWA605IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
724859Internal RxNorm lookup
724861Internal RxNorm lookup
724863Internal RxNorm lookup
805659Internal RxNorm lookup
805661Internal RxNorm lookup
805663Internal RxNorm lookup
861960Internal RxNorm lookup
861962Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d878aed0-ddbf-8fa1-abf7-d3e480260845Available on FDA.report

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
63459-215-07Nuvigil7 in 1 BLISTER PACKTABLET732
63459-215-30Nuvigil30 in 1 BOTTLETABLET3032
63459-215-35Nuvigil5 in 1 CARTONTABLET532

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-215-30EA - Each63459-215cb0ea318-ed28-45fe-bd13-515f3baaa04f12012-07-24
63459-215-60EA - Each63459-21592e87a54-8eec-4983-a45c-65b2fd38216712013-02-11

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
armodafinilACTIVE INGREDIENTV63XWA605INUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
armodafinilACTIVE MOIETYV63XWA605INUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48NUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
povidoneINACTIVE INGREDIENTFZ989GH94ENUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJNUVIGIL (ARMODAFINIL) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-215NUVIGIL (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
63459-215-35634590215355 BLISTER PACK in 1 CARTON (63459-215-35) > 7 TABLET in 1 BLISTER PACK (63459-215-07) 5 blister pack2009-05-260000-00-00NoNoCurrent