FDA.reportPublic FDA data

Nuvigil

Product NDC
60429-004
11-digit product format
604290004
Labeler code
60429
Product ID
60429-004_3dd48c06-8784-6926-e063-6294a90a7590
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
NDA021875
Marketing category
NDA
Marketing start
2007-06-15
Substance
ARMODAFINIL
Active strength
250 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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N021875-002NUVIGILARMODAFINIL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-03-26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2026-08-01 22:54:322026-06N021875-002NUVIGIL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-03-26a50c72e98297…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
ndc (product): 60429-004
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nuvigil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL250 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
3dd49302-f757-d945-e063-6294a90afcbaAvailable 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
60429-004-30Nuvigil30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-004-30EA - Each60429-004aab747ed-9cce-49d1-bcf8-37231148ce8d12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
861960armodafinil 200 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
724861armodafinil 250 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
724863armodafinil 50 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
805659Nuvigil 150 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
861962Nuvigil 200 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
805661NUVIGIL 250 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
805663NUVIGIL 50 MG Oral TabletPSN3dd49302-f757-d945-e063-6294a90afcba1
805659armodafinil 150 MG Oral Tablet [Nuvigil]SBD3dd49302-f757-d945-e063-6294a90afcba1
861962armodafinil 200 MG Oral Tablet [Nuvigil]SBD3dd49302-f757-d945-e063-6294a90afcba1
805661armodafinil 250 MG Oral Tablet [Nuvigil]SBD3dd49302-f757-d945-e063-6294a90afcba1
805663armodafinil 50 MG Oral Tablet [Nuvigil]SBD3dd49302-f757-d945-e063-6294a90afcba1
724859armodafinil 150 MG Oral TabletSCD3dd49302-f757-d945-e063-6294a90afcba1
861960armodafinil 200 MG Oral TabletSCD3dd49302-f757-d945-e063-6294a90afcba1
724861armodafinil 250 MG Oral TabletSCD3dd49302-f757-d945-e063-6294a90afcba1
724863armodafinil 50 MG Oral TabletSCD3dd49302-f757-d945-e063-6294a90afcba1
805659Nuvigil 150 MG Oral TabletSY3dd49302-f757-d945-e063-6294a90afcba1
861962Nuvigil 200 MG Oral TabletSY3dd49302-f757-d945-e063-6294a90afcba1
805661Nuvigil 250 MG Oral TabletSY3dd49302-f757-d945-e063-6294a90afcba1
805663Nuvigil 50 MG Oral TabletSY3dd49302-f757-d945-e063-6294a90afcba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60429-004-306042900043030 TABLET in 1 BOTTLE (60429-004-30) 30 tablet2025-07-30NoNoCurrent