Armodafinil

Product NDC
71335-1193
11-digit product format
713351193
Labeler code
71335
Product ID
71335-1193_0c5145ed-6785-4545-b59e-dc5ba22a07dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206069
Marketing category
ANDA
Marketing start
2018-03-06
Substance
ARMODAFINIL
Active strength
150 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
ARMODAFINIL150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV63XWA605I
Rxcui724859, 724861

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
71335-1193-1Armodafinil30 in 1 BOTTLETABLET309
71335-1193-2Armodafinil28 in 1 BOTTLETABLET289
71335-1193-3Armodafinil90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1193ARMODAFINIL TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 3 package rows20240410_cbe7c0d9-dfd2-4000-bd76-7fe3454ce64f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9
724861armodafinil 250 MG Oral TabletPSNcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9
724859armodafinil 150 MG Oral TabletSCDcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9
724861armodafinil 250 MG Oral TabletSCDcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1193-17133511930130 TABLET in 1 BOTTLE (71335-1193-1) 30 tablet2019-04-160000-00-00NoNoCurrent
71335-1193-27133511930228 TABLET in 1 BOTTLE (71335-1193-2) 28 tablet2024-04-030000-00-00NoNoCurrent
71335-1193-37133511930390 TABLET in 1 BOTTLE (71335-1193-3) 90 tablet2024-04-030000-00-00NoNoCurrent