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United States · US · US:72865-316_297988b4-69fb-4691-92e0-ee5da80b0125
TOPIRAMATE
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXLCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172865316101000 TABLET in 1 BOTTLE (72865-316-10)
- ndc11728653166060 TABLET in 1 BOTTLE (72865-316-60)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A215414
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": "72865-316_297988b4-69fb-4691-92e0-ee5da80b0125",
"productndc": "72865-316",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215414",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Aug 26, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Aug 26, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Aug 26, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Aug 26, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "TOPIRAMATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215414",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20250710",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AX11.
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