FDA.reportPublic FDA data

Armodafinil

Product NDC
65862-806
Requested package NDC
65862-806-05
11-digit product format
658620806
Labeler code
65862
Product ID
65862-806_09746c0a-9656-4f1d-a380-1cbe732c8e21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
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

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
A206069-001ARMODAFINILARMODAFINIL50MGTABLET / ORALAB2018-03-06
A206069-002ARMODAFINILARMODAFINIL150MGTABLET / ORALAB2018-03-06
A206069-003ARMODAFINILARMODAFINIL250MGTABLET / ORALAB2018-03-06
A206069-004ARMODAFINILARMODAFINIL200MGTABLET / ORALAB2018-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A206069-001AB
A206069-002AB
A206069-003AB
A206069-004AB

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 22:54:322026-06A206069-001ARMODAFINIL50MGTABLET / ORALAB2018-03-06a50c72e98297…
2026-08-01 22:54:322026-06A206069-002ARMODAFINIL150MGTABLET / ORALAB2018-03-06a50c72e98297…
2026-08-01 22:54:322026-06A206069-003ARMODAFINIL250MGTABLET / ORALAB2018-03-06a50c72e98297…
2026-08-01 22:54:322026-06A206069-004ARMODAFINIL200MGTABLET / ORALAB2018-12-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206069-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206069-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206069-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206069-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArmodafinilARMODAFINILPreferred Pharmaceuticals Inc.93b9f9a4-66d9-4ed9-8f2f-903e416e900d2026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206069
application number: ANDA206069
ArmodafinilARMODAFINILPreferred Pharmaceuticals Inc.4128759d-ed7c-4130-b24c-a0541f2b9e7f2026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206069
application number: ANDA206069
ArmodafinilARMODAFINILDirect_Rxfacd329b-1925-61df-e053-6294a90ab7382025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206069
application number: ANDA206069
ARMODAFINILARMODAFINILdirect rxb1ba1cdd-cf57-7a8c-e053-2a95a90a2c192025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206069
application number: ANDA206069
ArmodafinilARMODAFINILBryant Ranch Prepackcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206069
application number: ANDA206069
ArmodafinilARMODAFINILAurobindo Pharma Limited23da56b8-7552-4362-a1ab-e794c131194c2024-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206069
application number: ANDA206069
ndc (package): 65862-806-05
ndc (product): 65862-806
ndc11 (package): 65862080605

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V63XWA605IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
724859Internal RxNorm lookup
724861Internal RxNorm lookup
724863Internal RxNorm lookup
861960Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23da56b8-7552-4362-a1ab-e794c131194cAvailable on FDA.report

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
65862-806-05Armodafinil500 in 1 BOTTLETABLET5006
65862-806-30Armodafinil30 in 1 BOTTLETABLET306
65862-806-60Armodafinil60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-806-30EA - Each65862-806d7e46707-21dd-44bc-a5b4-8a5b29401fa612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-806ARMODAFINIL TABLET [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20240204_23da56b8-7552-4362-a1ab-e794c131194c.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
724859armodafinil 150 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletPSN4128759d-ed7c-4130-b24c-a0541f2b9e7f6
861960armodafinil 200 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724861armodafinil 250 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724863armodafinil 50 MG Oral TabletPSN23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletSCD4128759d-ed7c-4130-b24c-a0541f2b9e7f6
861960armodafinil 200 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724861armodafinil 250 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724863armodafinil 50 MG Oral TabletSCD23da56b8-7552-4362-a1ab-e794c131194c6
724859armodafinil 150 MG Oral TabletPSN91e82344-ef83-a838-e053-2995a90abd381
724859armodafinil 150 MG Oral TabletSCD91e82344-ef83-a838-e053-2995a90abd381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-806-0565862080605500 TABLET in 1 BOTTLE (65862-806-05) 500 tablet2018-03-060000-00-00NoNoCurrent