FDA.reportPublic FDA data

Nuvigil

Product NDC
60505-4850
11-digit product format
605054850
Labeler code
60505
Product ID
60505-4850_ab761afd-b864-a5f9-e204-952c98103e63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
NDA021875
Marketing category
NDA
Marketing start
2025-08-31
Substance
ARMODAFINIL
Active strength
250 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 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
60505-4850-3Nuvigil30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4850-3EA - Each60505-4850617fb7d6-7e93-4fd5-9718-95915cf8414812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
861960armodafinil 200 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
724861armodafinil 250 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
724863armodafinil 50 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
805659Nuvigil 150 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
861962Nuvigil 200 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
805661NUVIGIL 250 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
805663NUVIGIL 50 MG Oral TabletPSNa69631d0-1263-769e-b232-4ab9160e0fa32
805659armodafinil 150 MG Oral Tablet [Nuvigil]SBDa69631d0-1263-769e-b232-4ab9160e0fa32
861962armodafinil 200 MG Oral Tablet [Nuvigil]SBDa69631d0-1263-769e-b232-4ab9160e0fa32
805661armodafinil 250 MG Oral Tablet [Nuvigil]SBDa69631d0-1263-769e-b232-4ab9160e0fa32
805663armodafinil 50 MG Oral Tablet [Nuvigil]SBDa69631d0-1263-769e-b232-4ab9160e0fa32
724859armodafinil 150 MG Oral TabletSCDa69631d0-1263-769e-b232-4ab9160e0fa32
861960armodafinil 200 MG Oral TabletSCDa69631d0-1263-769e-b232-4ab9160e0fa32
724861armodafinil 250 MG Oral TabletSCDa69631d0-1263-769e-b232-4ab9160e0fa32
724863armodafinil 50 MG Oral TabletSCDa69631d0-1263-769e-b232-4ab9160e0fa32
805659Nuvigil 150 MG Oral TabletSYa69631d0-1263-769e-b232-4ab9160e0fa32
861962Nuvigil 200 MG Oral TabletSYa69631d0-1263-769e-b232-4ab9160e0fa32
805661Nuvigil 250 MG Oral TabletSYa69631d0-1263-769e-b232-4ab9160e0fa32
805663Nuvigil 50 MG Oral TabletSYa69631d0-1263-769e-b232-4ab9160e0fa32
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
60505-4850-36050548500330 TABLET in 1 BOTTLE (60505-4850-3) 30 tablet2025-08-31NoNoHistorical