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United States · US · US:68071-3088_1d9c84c2-11ef-726e-e063-6294a90a8c7c
Topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11680713088330 TABLET in 1 BOTTLE (68071-3088-3)
- ndc11680713088660 TABLET in 1 BOTTLE (68071-3088-6)
- ndc11680713088990 TABLET in 1 BOTTLE (68071-3088-9)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A076343
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": "68071-3088_1d9c84c2-11ef-726e-e063-6294a90a8c7c",
"productndc": "68071-3088",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076343",
"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": "ANDA076343",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20140612",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX11.
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