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United States · US · US:55253-801_428b6de2-f791-43db-a186-d19312a348fd
Modafinil
Orange BookUNIISPLATC N06BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCIMA LABS INC.
CountryUS (United States)
ATC codeN06BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11552538013030 TABLET in 1 BOTTLE (55253-801-30)
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": {
"1d4c6858-5b2f-f216-e063-6394a90aad5d": {
"match": "brand_token",
"title": "MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "3",
"published_date": "2026-03-18"
}
},
"productid": "55253-801_428b6de2-f791-43db-a186-d19312a348fd",
"productndc": "55253-801",
"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": "Modafinil",
"active_ingred_unit": "mg/1",
"application_number": "NDA020717",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Modafinil",
"start_marketing_date": "20120329",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N06BA07.
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