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United States · US · US:53746-734_b9ac064d-eed2-4d3c-b984-c9ebcef68646
Felbamate
Orange BookUNIISPLATC N03AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN03AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11537467343030 TABLET in 1 BOTTLE (53746-734-30)
- ndc11537467349090 TABLET in 1 BOTTLE (53746-734-90)
Annotations
UNII (FDA Substance ID)
X72RBB02N8
FELBAMATE
RxCUI 24812
Orange Book
A201680
ABAB
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": "53746-734_b9ac064d-eed2-4d3c-b984-c9ebcef68646",
"productndc": "53746-734",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "201680",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Sep 13, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Sep 13, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FELBAMATE",
"proprietary_name": "Felbamate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201680",
"marketing_category": "ANDA",
"nonproprietary_name": "Felbamate",
"start_marketing_date": "20220810",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code N03AX10.
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