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United States · US · US:71335-0337_e3f4055d-0748-4d91-9e6f-aeae4548579b
Topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11713350337160 TABLET in 1 BOTTLE (71335-0337-1)
- ndc11713350337230 TABLET in 1 BOTTLE (71335-0337-2)
- ndc11713350337390 TABLET in 1 BOTTLE (71335-0337-3)
- ndc117133503374120 TABLET in 1 BOTTLE (71335-0337-4)
- ndc11713350337550 TABLET in 1 BOTTLE (71335-0337-5)
- ndc11713350337614 TABLET in 1 BOTTLE (71335-0337-6)
- ndc11713350337745 TABLET in 1 BOTTLE (71335-0337-7)
- ndc1171335033787 TABLET in 1 BOTTLE (71335-0337-8)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A076343
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": "71335-0337_e3f4055d-0748-4d91-9e6f-aeae4548579b",
"productndc": "71335-0337",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076343",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Mar 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Mar 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Mar 27, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076343",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20140612",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX11.
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