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United States · US · US:68788-8828_288d6b40-8c87-4f16-85a7-86166b5ac77f
topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878888281100 TABLET, FILM COATED in 1 BOTTLE (68788-8828-1)
- ndc11687888828330 TABLET, FILM COATED in 1 BOTTLE (68788-8828-3)
- ndc11687888828515 TABLET, FILM COATED in 1 BOTTLE (68788-8828-5)
- ndc11687888828660 TABLET, FILM COATED in 1 BOTTLE (68788-8828-6)
- ndc11687888828990 TABLET, FILM COATED in 1 BOTTLE (68788-8828-9)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A090162
ABABABAB
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": "68788-8828_288d6b40-8c87-4f16-85a7-86166b5ac77f",
"productndc": "68788-8828",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090162",
"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": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Feb 19, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090162",
"marketing_category": "ANDA",
"nonproprietary_name": "topiramate",
"start_marketing_date": "20250214",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX11.
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