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United States · US · US:81033-035_4e91425f-55c5-d255-e063-6394a90a6f2f
TOPIRAMATE
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKesin Pharma
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A217795
AB
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": "81033-035_4e91425f-55c5-d255-e063-6394a90a6f2f",
"productndc": "81033-035",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "217795",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG/ML",
"product_no": "001",
"approval_date": "Oct 31, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "TOPIRAMATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217795",
"marketing_category": "ANDA",
"nonproprietary_name": "TOPIRAMATE",
"start_marketing_date": "20250707",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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