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United States · US · US:0245-1075_c282e476-f752-48da-ae0f-2987d682a4b8
QUDEXY
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1102451075301 BOTTLE in 1 CARTON (0245-1075-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
- ndc1102451075901 BOTTLE in 1 CARTON (0245-1075-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
N205122
AB2AB2AB2AB2AB2
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": {
"46f54677-3a22-4c38-9b92-923020164e15": {
"match": "brand_token",
"title": "QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "29",
"published_date": "2026-04-02"
}
},
"productid": "0245-1075_c282e476-f752-48da-ae0f-2987d682a4b8",
"productndc": "0245-1075",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "205122",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB2",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 11, 2014"
},
{
"rs": false,
"rld": true,
"te_code": "AB2",
"strength": "50MG",
"product_no": "002",
"approval_date": "Mar 11, 2014"
},
{
"rs": false,
"rld": true,
"te_code": "AB2",
"strength": "100MG",
"product_no": "003",
"approval_date": "Mar 11, 2014"
},
{
"rs": false,
"rld": true,
"te_code": "AB2",
"strength": "150MG",
"product_no": "004",
"approval_date": "Mar 11, 2014"
},
{
"rs": true,
"rld": true,
"te_code": "AB2",
"strength": "200MG",
"product_no": "005",
"approval_date": "Mar 11, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "QUDEXY",
"active_ingred_unit": "mg/1",
"application_number": "NDA205122",
"marketing_category": "NDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20140411",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code N03AX11.
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