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United States · US · US:68462-218_e4d3b13a-e354-421d-917a-613ad0a3ab35
Topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11684622186060 CAPSULE, COATED PELLETS in 1 BOTTLE (68462-218-60)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A217869
ABAB
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": "68462-218_e4d3b13a-e354-421d-917a-613ad0a3ab35",
"productndc": "68462-218",
"dosage_form": "CAPSULE, COATED PELLETS",
"orange_book": {
"appl_no": "217869",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Jul 16, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Jul 16, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217869",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20240716",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N03AX11.
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