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United States · US · US:63459-225_a70488d7-57ea-446e-89c2-87b0ecc90023
Nuvigil
Orange BookUNIISPLATC N06BA13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCephalon, LLC
CountryUS (United States)
ATC codeN06BA13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11634592253030 TABLET in 1 BOTTLE (63459-225-30)
Annotations
UNII (FDA Substance ID)
V63XWA605I
ARMODAFINIL
RxCUI 641465
Orange Book
N021875
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V63XWA605I",
"rxcui": "641465",
"inchikey": "YFGHCGITMMYXAQ-LJQANCHMSA-N",
"display_name": "ARMODAFINIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3dd49302-f757-d945-e063-6294a90afcba": {
"match": "brand_token",
"title": "NUVIGIL (ARMODAFINIL) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "1",
"published_date": "2025-09-05"
}
},
"productid": "63459-225_a70488d7-57ea-446e-89c2-87b0ecc90023",
"productndc": "63459-225",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "021875",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Jun 15, 2007"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Mar 26, 2009"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Jun 15, 2007"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "250MG",
"product_no": "004",
"approval_date": "Jun 15, 2007"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "005",
"approval_date": "Mar 26, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARMODAFINIL",
"proprietary_name": "Nuvigil",
"active_ingred_unit": "mg/1",
"application_number": "NDA021875",
"marketing_category": "NDA",
"nonproprietary_name": "Armodafinil",
"start_marketing_date": "20090526",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code N06BA13.
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