FDA.reportPublic FDA data

Armodafinil

Product NDC
68788-7880
11-digit product format
687887880
Labeler code
68788
Product ID
68788-7880_da87ba1c-5887-4492-8ae9-40a027d5e449
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206069
Marketing category
ANDA
Marketing start
2021-03-08
Substance
ARMODAFINIL
Active strength
150 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Armodafinil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV63XWA605I
Rxcui724859

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
68788-7880-3Armodafinil30 in 1 BOTTLETABLET306
68788-7880-6Armodafinil60 in 1 BOTTLETABLET606
68788-7880-9Armodafinil90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7880-3EA - Each68788-7880c728ce14-5f00-4ce6-a471-c1ca245fcacf12021-04-08
68788-7880-6EA - Each68788-788079edcae8-137f-48a0-98dc-7c7c37ef77d612021-04-08
68788-7880-9EA - Each68788-7880ea9cf9aa-d9d7-4095-b614-59232b3ab72612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7880ARMODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250205_4128759d-ed7c-4130-b24c-a0541f2b9e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSN4128759d-ed7c-4130-b24c-a0541f2b9e7f6
724859armodafinil 150 MG Oral TabletSCD4128759d-ed7c-4130-b24c-a0541f2b9e7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7880-36878878800330 TABLET in 1 BOTTLE (68788-7880-3) 30 tablet2021-03-080000-00-00NoNoCurrent
68788-7880-66878878800660 TABLET in 1 BOTTLE (68788-7880-6) 60 tablet2021-03-080000-00-00NoNoCurrent
68788-7880-96878878800990 TABLET in 1 BOTTLE (68788-7880-9) 90 tablet2021-03-080000-00-00NoNoCurrent