FDA.reportPublic FDA data

Armodafinil

Product NDC
69339-180
Requested package NDC
69339-180-03
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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202768-001ARMODAFINIL50MGTABLET / ORALAB2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A202768-002ARMODAFINIL150MGTABLET / ORALAB2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A202768-003ARMODAFINIL250MGTABLET / ORALAB2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A202768-004ARMODAFINIL100MGTABLET / ORALAB2017-09-28a50c72e98297…
2026-08-01 22:54:322026-06A202768-005ARMODAFINIL200MGTABLET / ORALAB2017-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202768-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202768-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202768-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202768-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202768-005AB1a50c72e98297…

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 · 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 (package): 69339-180-03
ndc (product): 69339-180
ndc11 (package): 69339018003

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

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