FDA.reportPublic FDA data

Armodafinil

Product NDC
55700-510
11-digit product format
557000510
Labeler code
55700
Product ID
55700-510_5e8316d5-1f2c-487b-8053-5507eecee36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
NDA021875
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-11-29
Marketing end
2027-09-30
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
Rxcui724861

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf31ebd7-fd9d-472c-88e1-94944f023ec0Product name320190628

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-510-302021-10-04C16284748780-1ba0f9c33-1ec2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Armodafinil Tablets safely and effectively. See full prescribing information for Armodafinil Tablets. Armodafinil Tablets, for oral use, C-IV Initial U.S. Approval: 2007
55700-510-302021-01-29C16284748780-1ba0f9c33-1ec2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Armodafinil Tablets safely and effectively. See full prescribing information for Armodafinil Tablets. Armodafinil Tablets, for oral use, C-IV Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-510-30Armodafinil30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-510-30EA - Each55700-51079425cdd-b8bf-4b82-ad2d-3a161be5a42612017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-510ARMODAFINIL TABLET [QUALITY CARE PRODUCTS LLC]8Current NDC, Legacy NDC, 1 package rows20250101_98338994-7818-4b86-ae98-cd08fa700879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724861armodafinil 250 MG Oral TabletPSN98338994-7818-4b86-ae98-cd08fa7008798
724861armodafinil 250 MG Oral TabletSCD98338994-7818-4b86-ae98-cd08fa7008798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-510-305570005103030 TABLET in 1 BOTTLE (55700-510-30) 30 tablet2016-11-292027-09-30NoNoCurrent