FDA.reportPublic FDA data

Armodafinil

Product NDC
61919-770
11-digit product format
619190770
Labeler code
61919
Product ID
61919-770_85a29824-058c-1411-e053-2a91aa0a451b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA200751
Marketing category
ANDA
Marketing start
2019-01-04
Marketing end
0000-00-00
Substance
ARMODAFINIL
Active strength
150 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-770IInactivated by FDA2026-07-31
excluded packagepackage61919-77061919-770-30IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200751-001ARMODAFINILARMODAFINIL50MGTABLET / ORAL2016-11-28
A200751-003ARMODAFINILARMODAFINIL150MGTABLET / ORAL2016-11-28
A200751-004ARMODAFINILARMODAFINIL200MGTABLET / ORAL2016-11-28
A200751-005ARMODAFINILARMODAFINIL250MGTABLET / ORAL2016-11-28

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
61919-770-30Armodafinil30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-770-30EA - Each61919-77040b20764-e45a-4ff7-a402-f30a8c97935612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-770ARMODAFINIL TABLET ARMODAFINIL TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20190404_7ea5430a-df28-e521-e053-2a91aa0a8f22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSN7ea5430a-df28-e521-e053-2a91aa0a8f222
724859armodafinil 150 MG Oral TabletSCD7ea5430a-df28-e521-e053-2a91aa0a8f222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-770-306191907703030 in 1 BOTTLEHistorical