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United States · US · US:67386-314_68dbe31c-2dbe-49ad-8b2e-2cf1b8521167
Onfi
Orange BookUNIISPLATC N05BA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLundbeck Pharmaceuticals LLC
CountryUS (United States)
ATC codeN05BA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167386314011 BOTTLE in 1 CARTON (67386-314-01) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2MRO291B4U
CLOBAZAM
RxCUI 21241
Orange Book
N202067
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2MRO291B4U",
"rxcui": "21241",
"inchikey": "CXOXHMZGEKVPMT-UHFFFAOYSA-N",
"display_name": "CLOBAZAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"de03bd69-2dca-459c-93b4-541fd3e9571c": {
"match": "brand_token",
"title": "ONFI (CLOBAZAM) TABLET ONFI (CLOBAZAM) SUSPENSION [LUNDBECK PHARMACEUTICALS LLC]",
"spl_version": "42",
"published_date": "2025-12-17"
}
},
"productid": "67386-314_68dbe31c-2dbe-49ad-8b2e-2cf1b8521167",
"productndc": "67386-314",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202067",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Oct 21, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 21, 2011"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Oct 21, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOBAZAM",
"proprietary_name": "Onfi",
"active_ingred_unit": "mg/1",
"application_number": "NDA202067",
"marketing_category": "NDA",
"nonproprietary_name": "clobazam",
"start_marketing_date": "20131210",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BA09.
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