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United States · US · US:17772-103_4d7bcc14-c816-0b67-e063-6394a90a1097
Trokendi XR
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSupernus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc111777210301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01)
- ndc1117772103077 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-07)
- ndc1117772103105 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10)
- ndc1117772103127 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-12)
- ndc11177721033030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-30)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
N201635
AB1AB1AB1AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0H73WJJ391",
"rxcui": "38404",
"inchikey": "KJADKKWYZYXHBB-XBWDGYHZSA-N",
"display_name": "TOPIRAMATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2dc7957e-a3e5-46bb-aa66-f3250f872f5e": {
"match": "brand_token",
"title": "TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]",
"spl_version": "29",
"published_date": "2026-03-23"
}
},
"productid": "17772-103_4d7bcc14-c816-0b67-e063-6394a90a1097",
"productndc": "17772-103",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "201635",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB1",
"strength": "25MG",
"product_no": "001",
"approval_date": "Aug 16, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB1",
"strength": "50MG",
"product_no": "002",
"approval_date": "Aug 16, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB1",
"strength": "100MG",
"product_no": "003",
"approval_date": "Aug 16, 2013"
},
{
"rs": true,
"rld": true,
"te_code": "AB1",
"strength": "200MG",
"product_no": "004",
"approval_date": "Aug 16, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Trokendi XR",
"active_ingred_unit": "mg/1",
"application_number": "NDA201635",
"marketing_category": "NDA",
"nonproprietary_name": "topiramate",
"start_marketing_date": "20130816",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX11.
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