FDA.reportPublic FDA data

Armodafinil

Product NDC
68788-7826
11-digit product format
687887826
Labeler code
68788
Product ID
68788-7826_8f3858c1-8fd9-49cf-a1fa-e4d11d4ce86b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206069
Marketing category
ANDA
Marketing start
2021-01-05
Substance
ARMODAFINIL
Active strength
200 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
ARMODAFINIL200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV63XWA605I
Rxcui861960

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
68788-7826-3Armodafinil30 in 1 BOTTLETABLET306
68788-7826-6Armodafinil60 in 1 BOTTLETABLET606
68788-7826-9Armodafinil90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7826-3EA - Each68788-782647b1e489-4d42-4805-a35b-96e7470b8ea512021-02-05
68788-7826-6EA - Each68788-7826325f8b33-a68d-469d-9ea5-ead20a6e3bb912021-02-05
68788-7826-9EA - Each68788-78261ca33912-f264-42ff-946d-04d4e450095b12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7826ARMODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250205_93b9f9a4-66d9-4ed9-8f2f-903e416e900d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861960armodafinil 200 MG Oral TabletPSN93b9f9a4-66d9-4ed9-8f2f-903e416e900d6
861960armodafinil 200 MG Oral TabletSCD93b9f9a4-66d9-4ed9-8f2f-903e416e900d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7826-36878878260330 TABLET in 1 BOTTLE (68788-7826-3) 30 tablet2021-01-050000-00-00NoNoCurrent
68788-7826-66878878260660 TABLET in 1 BOTTLE (68788-7826-6) 60 tablet2021-01-050000-00-00NoNoCurrent
68788-7826-96878878260990 TABLET in 1 BOTTLE (68788-7826-9) 90 tablet2021-01-050000-00-00NoNoCurrent