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United States · US · US:68788-8817_521be3f1-3ee7-45c7-9f0c-17e08b6c8fca
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
- ndc11687888817330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-3)
- ndc11687888817515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-5)
- ndc11687888817660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-6)
- ndc116878888178120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-8)
- ndc11687888817990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-9)
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": "68788-8817_521be3f1-3ee7-45c7-9f0c-17e08b6c8fca",
"productndc": "68788-8817",
"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": "20250121",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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