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United States · US · US:65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f
Felbamate
Orange BookUNIISPLATC N03AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116516268688237 mL in 1 BOTTLE (65162-686-88)
- ndc116516268690473 mL in 1 BOTTLE (65162-686-90)
Annotations
UNII (FDA Substance ID)
X72RBB02N8
FELBAMATE
RxCUI 24812
Orange Book
A202385
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": "65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f",
"productndc": "65162-686",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "202385",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG/5ML",
"product_no": "001",
"approval_date": "Dec 16, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FELBAMATE",
"proprietary_name": "Felbamate",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA202385",
"marketing_category": "ANDA",
"nonproprietary_name": "Felbamate",
"start_marketing_date": "20111216",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N03AX10.
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- 🇺🇸FelbamateANI Pharmaceuticals, Inc.
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- 🇺🇸FelbamateTaro Pharmaceuticals U.S.A., inc.
- 🇺🇸FelbamateTaro Pharmaceuticals U.S.A., Inc.
- 🇺🇸FelbamateAmneal Pharmaceuticals of New York LLC
- 🇺🇸FelbamateAmneal Pharmaceuticals LLC
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