Armodafinil

Product NDC
69339-180
11-digit product format
693390180
Labeler code
69339
Product ID
69339-180_d93dca81-a0da-49ee-be61-86e713ab56cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA202768
Marketing category
ANDA
Marketing start
2023-03-23
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
Armodafinil
Listing expiration
2026-12-31

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
69339-180-03Armodafinil30 in 1 BOTTLETABLET302
69339-180-05Armodafinil500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-180-03EA - Each69339-18097f11c34-da3d-41a6-9f10-196e7c22dabc12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-180ARMODAFINIL TABLET [NATCO PHARMA USA LLC]2Current NDC, 2 package rows20240118_de2f0921-e791-426c-9192-2b7162e2158c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
861960armodafinil 200 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
724861armodafinil 250 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
724863armodafinil 50 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
724859armodafinil 150 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2
861960armodafinil 200 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2
724861armodafinil 250 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2
724863armodafinil 50 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69339-180-036933901800330 TABLET in 1 BOTTLE (69339-180-03) 30 tablet2023-03-23NoNoHistorical
69339-180-0569339018005500 TABLET in 1 BOTTLE (69339-180-05) 500 tablet2023-03-23NoNoHistorical