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United States · US · US:68418-7941_7c968964-991e-4ec2-bc03-ef062b5bb0f9
Diacomit
Orange BookUNIISPLATC N03AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBIOCODEX, INC.
CountryUS (United States)
ATC codeN03AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11684187941660 PACKET in 1 CARTON (68418-7941-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET
Annotations
UNII (FDA Substance ID)
R02XOT8V8I
STIRIPENTOL
RxCUI 2054968
Orange Book
N207223
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R02XOT8V8I",
"rxcui": "2054968",
"inchikey": "IBLNKMRFIPWSOY-FNORWQNLSA-N",
"display_name": "STIRIPENTOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"58304ba8-9779-4658-811e-94ffe08c3f16": {
"match": "brand_token",
"title": "DIACOMIT (STIRIPENTOL) CAPSULE DIACOMIT (STIRIPENTOL) POWDER, FOR SUSPENSION [BIOCODEX, INC.]",
"spl_version": "8",
"published_date": "2026-04-30"
}
},
"productid": "68418-7941_7c968964-991e-4ec2-bc03-ef062b5bb0f9",
"productndc": "68418-7941",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "207223",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "250MG/PACKET",
"product_no": "001",
"approval_date": "Aug 20, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG/PACKET",
"product_no": "002",
"approval_date": "Aug 20, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "STIRIPENTOL",
"proprietary_name": "Diacomit",
"active_ingred_unit": "mg/1",
"application_number": "NDA207223",
"marketing_category": "NDA",
"nonproprietary_name": "stiripentol",
"start_marketing_date": "20180821",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code N03AX17.
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