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United States · US · US:70771-1316_709dd70b-24e1-435f-8373-02e6dd538b2c
Topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117077113161100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-1)
- ndc11707711316330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-3)
- ndc11707711316410 BLISTER PACK in 1 CARTON (70771-1316-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1316-2)
- ndc117077113165500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-5)
- ndc11707711316990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-9)
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": "70771-1316_709dd70b-24e1-435f-8373-02e6dd538b2c",
"productndc": "70771-1316",
"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": "20180405",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX11.
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