🇺🇸
United States · US · US:70771-1077_785f1747-e29d-432a-82e7-fcaeea202327
Felbamate
Orange BookUNIISPLATC N03AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN03AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117077110771100 TABLET in 1 BOTTLE (70771-1077-1)
- ndc11707711077330 TABLET in 1 BOTTLE (70771-1077-3)
- ndc11707711077410 BLISTER PACK in 1 CARTON (70771-1077-4) / 10 TABLET in 1 BLISTER PACK
- ndc117077110775500 TABLET in 1 BOTTLE (70771-1077-5)
- ndc11707711077990 TABLET in 1 BOTTLE (70771-1077-9)
Annotations
UNII (FDA Substance ID)
X72RBB02N8
FELBAMATE
RxCUI 24812
Orange Book
A208970
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": "70771-1077_785f1747-e29d-432a-82e7-fcaeea202327",
"productndc": "70771-1077",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208970",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "May 30, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "May 30, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FELBAMATE",
"proprietary_name": "Felbamate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208970",
"marketing_category": "ANDA",
"nonproprietary_name": "Felbamate",
"start_marketing_date": "20170815",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code N03AX10.
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- 🇺🇸FelbamateNORTHSTAR RX LLC
- 🇺🇸FelbamateTaro Pharmaceuticals U.S.A., inc.
- 🇺🇸FelbamateTaro Pharmaceuticals U.S.A., Inc.
- 🇺🇸FelbamateAmneal Pharmaceuticals of New York LLC
- 🇺🇸FelbamateViona Pharmaceuticals Inc
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