Armodafinil

Product NDC
0781-8053
11-digit product format
007818053
Labeler code
0781
Product ID
0781-8053_dea0ad34-a35f-42ba-a6b6-dea58a16868f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021875
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-12-01
Marketing end
2028-06-30
Substance
ARMODAFINIL
Active strength
250 mg/1
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Armodafinil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL250 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
0781-8053-31Armodafinil30 in 1 BOTTLETABLET3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-8053-31EA - Each0781-8053ed8d07bd-fa64-453a-bdb7-09f189d0b60c12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8053ARMODAFINIL TABLET [SANDOZ INC]14Current NDC, Legacy NDC, 1 package rows20240828_a3341ec8-1ad4-49e2-922b-13d1b30c8c1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
861960armodafinil 200 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724861armodafinil 250 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724863armodafinil 50 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724859armodafinil 150 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
861960armodafinil 200 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724861armodafinil 250 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724863armodafinil 50 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724861armodafinil 250 MG Oral TabletPSNb1ba1cdd-cf57-7a8c-e053-2a95a90a2c194
724861armodafinil 250 MG Oral TabletSCDb1ba1cdd-cf57-7a8c-e053-2a95a90a2c194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-8053-310078180533130 TABLET in 1 BOTTLE (0781-8053-31) 30 tablet2016-12-012028-06-30NoNoCurrent