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United States · US · US:68788-7460_6db355d5-503b-4993-963b-95c22c345ec4
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
- ndc11687887460330 TABLET, FILM COATED in 1 BOTTLE (68788-7460-3)
- ndc11687887460515 TABLET, FILM COATED in 1 BOTTLE (68788-7460-5)
- ndc11687887460660 TABLET, FILM COATED in 1 BOTTLE (68788-7460-6)
- ndc116878874608120 TABLET, FILM COATED in 1 BOTTLE (68788-7460-8)
- ndc11687887460990 TABLET, FILM COATED in 1 BOTTLE (68788-7460-9)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A078235
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": "68788-7460_6db355d5-503b-4993-963b-95c22c345ec4",
"productndc": "68788-7460",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078235",
"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": "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": "ANDA078235",
"marketing_category": "ANDA",
"nonproprietary_name": "topiramate",
"start_marketing_date": "20090327",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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