Armodafinil

Product NDC
69339-180
11-digit product format
693390180
Labeler code
69339
Product ID
69339-180_d93dca81-a0da-49ee-be61-86e713ab56cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA202768
Marketing category
ANDA
Marketing start
2023-03-23
Substance
ARMODAFINIL
Active strength
250 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 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202768-001ARMODAFINILARMODAFINIL50MGTABLET / ORALAB2016-11-28
A202768-002ARMODAFINILARMODAFINIL150MGTABLET / ORALAB2016-11-28
A202768-003ARMODAFINILARMODAFINIL250MGTABLET / ORALAB2016-11-28
A202768-004ARMODAFINILARMODAFINIL100MGTABLET / ORALAB2017-09-28
A202768-005ARMODAFINILARMODAFINIL200MGTABLET / ORALAB2017-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202768-001AB
A202768-002AB
A202768-003AB
A202768-004AB
A202768-005AB

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.

Product history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-282680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202768-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202768-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202768-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202768-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202768-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202768-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202768-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202768-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202768-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202768-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202768-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Armodafinil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARMODAFINIL250 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
de2f0921-e791-426c-9192-2b7162e2158cAvailable 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
69339-180-03Armodafinil30 in 1 BOTTLETABLET302
69339-180-05Armodafinil500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-180-03EA - Each69339-18097f11c34-da3d-41a6-9f10-196e7c22dabc12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-180ARMODAFINIL TABLET [NATCO PHARMA USA LLC]2Current NDC, 2 package rows20240118_de2f0921-e791-426c-9192-2b7162e2158c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArmodafinilARMODAFINILNatco Pharma USA LLCde2f0921-e791-426c-9192-2b7162e2158c2023-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202768
application number: ANDA202768
ndc (product): 69339-180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
861960armodafinil 200 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
724861armodafinil 250 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
724863armodafinil 50 MG Oral TabletPSNde2f0921-e791-426c-9192-2b7162e2158c2
724859armodafinil 150 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2
861960armodafinil 200 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2
724861armodafinil 250 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2
724863armodafinil 50 MG Oral TabletSCDde2f0921-e791-426c-9192-2b7162e2158c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69339-180-036933901800330 TABLET in 1 BOTTLE (69339-180-03) 30 tablet2023-03-23NoNoCurrent
69339-180-0569339018005500 TABLET in 1 BOTTLE (69339-180-05) 500 tablet2023-03-23NoNoCurrent