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United States · US · US:70710-1040_bb736981-167f-4de6-a285-0e840ae37fc7
Topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707101040330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1040-3)
- ndc11707101040990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1040-9)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A208949
AB2AB2AB2AB2AB2
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": "70710-1040_bb736981-167f-4de6-a285-0e840ae37fc7",
"productndc": "70710-1040",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208949",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "25MG",
"product_no": "001",
"approval_date": "Nov 29, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "50MG",
"product_no": "002",
"approval_date": "Nov 29, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "100MG",
"product_no": "003",
"approval_date": "Nov 29, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "150MG",
"product_no": "004",
"approval_date": "Nov 29, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "200MG",
"product_no": "005",
"approval_date": "Nov 29, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208949",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20230117",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX11.
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