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United States · US · US:71335-0925_192309c7-4225-4515-93ac-94d05a0ad015
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 · 6
- ndc11713350925130 TABLET, FILM COATED in 1 BOTTLE (71335-0925-1)
- ndc11713350925260 TABLET, FILM COATED in 1 BOTTLE (71335-0925-2)
- ndc11713350925390 TABLET, FILM COATED in 1 BOTTLE (71335-0925-3)
- ndc117133509254120 TABLET, FILM COATED in 1 BOTTLE (71335-0925-4)
- ndc11713350925528 TABLET, FILM COATED in 1 BOTTLE (71335-0925-5)
- ndc11713350925620 TABLET, FILM COATED in 1 BOTTLE (71335-0925-6)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A090278
ABABAB
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": "71335-0925_192309c7-4225-4515-93ac-94d05a0ad015",
"productndc": "71335-0925",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090278",
"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": null,
"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": "ANDA090278",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20141215",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AX11.
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