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United States · US · US:63459-201_a505a386-c2a1-4a32-9523-b33b1528fb48
Provigil
Orange BookUNIISPLATC N06BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCephalon, LLC
CountryUS (United States)
ATC codeN06BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11634592013030 TABLET in 1 BOTTLE (63459-201-30)
Annotations
UNII (FDA Substance ID)
R3UK8X3U3D
MODAFINIL
RxCUI 30125
Orange Book
N020717
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R3UK8X3U3D",
"rxcui": "30125",
"inchikey": "YFGHCGITMMYXAQ-UHFFFAOYSA-N",
"display_name": "MODAFINIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3b8d1c32-dac9-50e6-e063-6394a90aa5a5": {
"match": "brand_token",
"title": "PROVIGIL (MODAFINIL) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "2",
"published_date": "2025-12-10"
}
},
"productid": "63459-201_a505a386-c2a1-4a32-9523-b33b1528fb48",
"productndc": "63459-201",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "020717",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Dec 24, 1998"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Dec 24, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MODAFINIL",
"proprietary_name": "Provigil",
"active_ingred_unit": "mg/1",
"application_number": "NDA020717",
"marketing_category": "NDA",
"nonproprietary_name": "Modafinil",
"start_marketing_date": "19990215",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N06BA07.
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