FDA.reportPublic FDA data

Armodafinil

Product NDC
65862-806
11-digit product format
658620806
Labeler code
65862
Product ID
65862-806_09746c0a-9656-4f1d-a380-1cbe732c8e21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206069
Marketing category
ANDA
Marketing start
2018-03-06
Substance
ARMODAFINIL
Active strength
150 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
Armodafinil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV63XWA605I
Rxcui724859, 724861, 724863, 861960

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
65862-806-05Armodafinil500 in 1 BOTTLETABLET5006
65862-806-30Armodafinil30 in 1 BOTTLETABLET306
65862-806-60Armodafinil60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-806-30EA - Each65862-806d7e46707-21dd-44bc-a5b4-8a5b29401fa612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-806ARMODAFINIL TABLET [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20240204_23da56b8-7552-4362-a1ab-e794c131194c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9
724861armodafinil 250 MG Oral TabletPSNcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9
724859armodafinil 150 MG Oral TabletSCDcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9
724861armodafinil 250 MG Oral TabletSCDcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9
724859armodafinil 150 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletPSN4128759d-ed7c-4130-b24c-a0541f2b9e7f6
861960armodafinil 200 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724861armodafinil 250 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724863armodafinil 50 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletSCD4128759d-ed7c-4130-b24c-a0541f2b9e7f6
861960armodafinil 200 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724861armodafinil 250 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724863armodafinil 50 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletPSN91e82344-ef83-a838-e053-2995a90abd381
724859armodafinil 150 MG Oral TabletSCD91e82344-ef83-a838-e053-2995a90abd381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-806-0565862080605500 TABLET in 1 BOTTLE (65862-806-05) 500 tablet2018-03-060000-00-00NoNoCurrent
65862-806-306586208063030 TABLET in 1 BOTTLE (65862-806-30) 30 tablet2018-03-060000-00-00NoNoCurrent
65862-806-606586208066060 TABLET in 1 BOTTLE (65862-806-60) 60 tablet2018-03-060000-00-00NoNoCurrent