🇺🇸
United States · US · US:59651-452_f12f3b94-ddf4-4fe0-ba06-01e4ffad1b71
TOPIRAMATE
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11596514526060 CAPSULE in 1 BOTTLE (59651-452-60)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A215449
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": "59651-452_f12f3b94-ddf4-4fe0-ba06-01e4ffad1b71",
"productndc": "59651-452",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215449",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Sep 27, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Sep 27, 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": "ANDA215449",
"marketing_category": "ANDA",
"nonproprietary_name": "TOPIRAMATE",
"start_marketing_date": "20230927",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N03AX11.
Access this data programmatically
Query TOPIRAMATE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.