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United States · US · US:10370-365_f7bcb5d1-262e-4d6b-8eb9-50d55a292dfc
Topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111037036501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-365-01)
- ndc11103703651130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-365-11)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A205976
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": {
"4e914420-a65b-98ba-e063-6394a90a14c4": {
"match": "brand_token",
"title": "TOPIRAMATE SOLUTION [KESIN PHARMA]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "10370-365_f7bcb5d1-262e-4d6b-8eb9-50d55a292dfc",
"productndc": "10370-365",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "205976",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "200MG",
"product_no": "001",
"approval_date": "Mar 1, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "25MG",
"product_no": "002",
"approval_date": "May 4, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "50MG",
"product_no": "003",
"approval_date": "May 4, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "100MG",
"product_no": "004",
"approval_date": "May 4, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205976",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20230524",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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