FDA.reportPublic FDA data

Armodafinil

Product NDC
71335-0681
Requested package NDC
71335-0681-3
11-digit product format
713350681
Labeler code
71335
Product ID
71335-0681_d8558bc2-6354-454a-81e9-3fad93f276f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200751
Marketing category
ANDA
Marketing start
2016-11-28
Marketing end
0000-00-00
Substance
ARMODAFINIL
Active strength
150 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-068171335-0681-3DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200751-001ARMODAFINIL50MGTABLET / ORAL2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A200751-003ARMODAFINIL150MGTABLET / ORAL2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A200751-004ARMODAFINIL200MGTABLET / ORAL2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A200751-005ARMODAFINIL250MGTABLET / ORAL2016-11-28a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0681-12020-06-14C16284748780-19d75b9d0-cbfb-f424-e053-dadaa90a57ceThese 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
71335-0681-22020-06-14C16284748780-19d75b9d0-cbfb-f424-e053-dadaa90a57ceThese 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
71335-0681-32020-06-14C16284748780-19d75b9d0-cbfb-f424-e053-dadaa90a57ceThese 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
71335-0681-12020-01-31C16284748780-19d75b9d0-cbfb-f424-e053-dadaa90a57ceThese 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
71335-0681-22020-01-31C16284748780-19d75b9d0-cbfb-f424-e053-dadaa90a57ceThese 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
71335-0681-32020-01-31C16284748780-19d75b9d0-cbfb-f424-e053-dadaa90a57ceThese 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0681-1EA - Each71335-0681fd5e9746-0ffd-45a8-87a6-b413550910a612022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0681-37133506810390 TABLET in 1 BOTTLE (71335-0681-3) 90 tablet2018-02-130000-00-00NoNoCurrent