FDA.reportPublic FDA data

Armodafinil

Product NDC
68180-573
Requested package NDC
68180-573-07
11-digit product format
681800573
Labeler code
68180
Product ID
68180-573_b4c0895d-90c6-4624-98fb-978e2c2893e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA200751
Marketing category
ANDA
Marketing start
2016-11-28
Marketing end
0000-00-00
Substance
ARMODAFINIL
Active strength
250 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 packagepackage68180-57368180-573-07DDiscontinued 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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-573-02EA - Each68180-5737e1b8724-6c9f-40ac-8a75-d540f4cd798c12016-12-07
68180-573-07EA - Each68180-5735ede44b1-1847-4d57-98b2-d0186fd578e612016-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-573-076818005730760 TABLET in 1 BOTTLE (68180-573-07) 60 tablet2016-11-280000-00-00NoNoCurrent