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United States · US · US:68382-863_2535bcc8-fac7-4b15-8c6f-fd6675655fd3
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 · 5
- ndc116838286301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-01)
- ndc116838286305500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-05)
- ndc11683828630630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-06)
- ndc11683828631690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-16)
- ndc1168382863783 BLISTER PACK in 1 CARTON (68382-863-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A207382
AB1AB1AB1AB1
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": "68382-863_2535bcc8-fac7-4b15-8c6f-fd6675655fd3",
"productndc": "68382-863",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "207382",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "25MG",
"product_no": "001",
"approval_date": "Nov 24, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "50MG",
"product_no": "002",
"approval_date": "Nov 24, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "100MG",
"product_no": "003",
"approval_date": "Nov 24, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "200MG",
"product_no": "004",
"approval_date": "Oct 30, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207382",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20240910",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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