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United States · US · US:24979-211_32ce22e7-a399-440d-bb5b-db2e412c2d95
Topiramate
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 · 1
- ndc11249792110460 CAPSULE in 1 PACKAGE (24979-211-04)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A217694
ABAB
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": "24979-211_32ce22e7-a399-440d-bb5b-db2e412c2d95",
"productndc": "24979-211",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217694",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Dec 5, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Dec 5, 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": "ANDA217694",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20231205",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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