🇺🇸
United States · US · US:70954-051_ca7073d4-4e4c-48b5-892a-2c33fa54062d
Felbamate
Orange BookUNIISPLATC N03AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovitium Pharma LLC
CountryUS (United States)
ATC codeN03AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117095405110237 mL in 1 BOTTLE (70954-051-10)
- ndc117095405120473 mL in 1 BOTTLE (70954-051-20)
Annotations
UNII (FDA Substance ID)
X72RBB02N8
FELBAMATE
RxCUI 24812
Orange Book
A211333
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X72RBB02N8",
"rxcui": "24812",
"inchikey": "WKGXYQFOCVYPAC-UHFFFAOYSA-N",
"display_name": "FELBAMATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"696e3cbb-a431-4f29-acbd-1db8e9aaef93": {
"match": "brand_token",
"title": "FELBAMATE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-03-30"
}
},
"productid": "70954-051_ca7073d4-4e4c-48b5-892a-2c33fa54062d",
"productndc": "70954-051",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "211333",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "600MG/5ML",
"product_no": "001",
"approval_date": "May 31, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FELBAMATE",
"proprietary_name": "Felbamate",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA211333",
"marketing_category": "ANDA",
"nonproprietary_name": "Felbamate",
"start_marketing_date": "20220715",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N03AX10.
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- 🇺🇸FelbamateTaro Pharmaceuticals U.S.A., inc.
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