FDA.reportPublic FDA data

Armodafinil

Product NDC
0781-8037
Requested package NDC
0781-8037-31
11-digit product format
007818037
Labeler code
0781
Product ID
0781-8037_dea0ad34-a35f-42ba-a6b6-dea58a16868f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Armodafinil
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021875
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-12-01
Marketing end
2028-06-30
Substance
ARMODAFINIL
Active strength
150 mg/1
DEA schedule
CIV
NDC exclude flag
No
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
N021875-001NUVIGILARMODAFINIL50MGTABLET / ORALABRLD2007-06-15
N021875-002NUVIGILARMODAFINIL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-03-26
N021875-003NUVIGILARMODAFINIL150MGTABLET / ORALABRLD2007-06-15
N021875-004NUVIGILARMODAFINIL250MGTABLET / ORALABRLD, RS2007-06-15
N021875-005NUVIGILARMODAFINIL200MGTABLET / ORALABRLD2009-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021875-001AB
N021875-003AB
N021875-004AB
N021875-005AB

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 22:54:322026-06N021875-001NUVIGIL50MGTABLET / ORALABRLD2007-06-15a50c72e98297…
2026-08-01 22:54:322026-06N021875-002NUVIGIL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-03-26a50c72e98297…
2026-08-01 22:54:322026-06N021875-003NUVIGIL150MGTABLET / ORALABRLD2007-06-15a50c72e98297…
2026-08-01 22:54:322026-06N021875-004NUVIGIL250MGTABLET / ORALABRLD, RS2007-06-15a50c72e98297…
2026-08-01 22:54:322026-06N021875-005NUVIGIL200MGTABLET / ORALABRLD2009-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021875-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021875-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021875-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N021875-005AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuvigilARMODAFINILGolden State Medical Supply, Inc.3dd49302-f757-d945-e063-6294a90afcba2025-09-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
NuvigilARMODAFINILApotex Corp.a69631d0-1263-769e-b232-4ab9160e0fa32025-08-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ARMODAFINILARMODAFINILDirectRxddd06dab-0855-5b4e-e053-2a95a90a5e672025-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ARMODAFINILARMODAFINILdirect rxb1ba1cdd-cf57-7a8c-e053-2a95a90a2c192025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ArmodafinilARMODAFINILQuality Care Products LLC98338994-7818-4b86-ae98-cd08fa7008792024-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ArmodafinilARMODAFINILTeva Pharmaceuticals USA, Inc.b3cac300-c3d2-4189-a410-2aaf3773c0902023-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ArmodafinilARMODAFINILSandoz Inca3341ec8-1ad4-49e2-922b-13d1b30c8c1d2023-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875
ndc (package): 0781-8037-31
ndc (product): 0781-8037
ndc11 (package): 00781803731
NuvigilARMODAFINILCephalon, LLCd878aed0-ddbf-8fa1-abf7-d3e4802608452022-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021875
application number: NDA021875

Additional Listing Data#

Finished product
Yes
Brand name base
Armodafinil

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
a3341ec8-1ad4-49e2-922b-13d1b30c8c1dAvailable 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
0781-8037-31Armodafinil30 in 1 BOTTLETABLET3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-8037-31EA - Each0781-80373606a3cc-9baf-41a1-8243-54e27092292512016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8037ARMODAFINIL TABLET [SANDOZ INC]14Current NDC, Legacy NDC, 1 package rows20240828_a3341ec8-1ad4-49e2-922b-13d1b30c8c1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724859armodafinil 150 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
861960armodafinil 200 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724861armodafinil 250 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724863armodafinil 50 MG Oral TabletPSNa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724859armodafinil 150 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
861960armodafinil 200 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724861armodafinil 250 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724863armodafinil 50 MG Oral TabletSCDa3341ec8-1ad4-49e2-922b-13d1b30c8c1d16
724859armodafinil 150 MG Oral TabletPSN7ea5430a-df28-e521-e053-2a91aa0a8f222
724859armodafinil 150 MG Oral TabletSCD7ea5430a-df28-e521-e053-2a91aa0a8f222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-8037-310078180373130 TABLET in 1 BOTTLE (0781-8037-31) 30 tablet2016-12-012028-06-30NoNoCurrent