Nuvigil

Product NDC
42254-014
11-digit product format
422540014
Labeler code
42254
Product ID
42254-014_10f918f7-4782-470e-a50e-35c7c66bfd79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021875
Marketing category
NDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
ARMODAFINIL
Active strength
50 mg/1
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf31ebd7-fd9d-472c-88e1-94944f023ec0Product name320190628

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-014-302019-09-24C16284748780-19350213a-3c3e-c013-e053-90daa90a1393NUVIGIL ® (armodafinil) Tablets [C-IV]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-014-30Nuvigil30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-014-30EA - Each42254-0148a40fc5d-dccb-4f5a-965c-8c336cf1497c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
armodafinilACTIVE INGREDIENTV63XWA605INUVIGIL (ARMODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
armodafinilACTIVE MOIETYV63XWA605INUVIGIL (ARMODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-014NUVIGIL (ARMODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20111216_10f918f7-4782-470e-a50e-35c7c66bfd79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724863armodafinil 50 MG Oral TabletPSN10f918f7-4782-470e-a50e-35c7c66bfd791
805663NUVIGIL 50 MG Oral TabletPSN10f918f7-4782-470e-a50e-35c7c66bfd791
805663armodafinil 50 MG Oral Tablet [Nuvigil]SBD10f918f7-4782-470e-a50e-35c7c66bfd791
724863armodafinil 50 MG Oral TabletSCD10f918f7-4782-470e-a50e-35c7c66bfd791
805663Nuvigil 50 MG Oral TabletSY10f918f7-4782-470e-a50e-35c7c66bfd791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-014-304225400143030 in 1 BOTTLEHistorical