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United States · US · US:62756-711_b8c52970-05b0-43ea-9122-566998bf4524
Topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116275671108100 TABLET, FILM COATED in 1 BOTTLE (62756-711-08)
- ndc116275671113500 TABLET, FILM COATED in 1 BOTTLE (62756-711-13)
- ndc1162756711181000 TABLET, FILM COATED in 1 BOTTLE (62756-711-18)
- ndc11627567118330 TABLET, FILM COATED in 1 BOTTLE (62756-711-83)
- ndc11627567118660 TABLET, FILM COATED in 1 BOTTLE (62756-711-86)
- ndc116275671188100 TABLET, FILM COATED in 1 BOTTLE (62756-711-88)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A090278
ABABAB
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": "62756-711_b8c52970-05b0-43ea-9122-566998bf4524",
"productndc": "62756-711",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090278",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Mar 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Mar 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "004",
"approval_date": "Mar 27, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090278",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20090327",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX11.
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