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United States · US · US:70518-4515_4d272d99-aebe-576f-e063-6394a90ae17b
topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117051845150120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-0)
- ndc11705184515130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4515-1)
- ndc11705184515260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-2)
- ndc117051845153120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-3)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A090162
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": "70518-4515_4d272d99-aebe-576f-e063-6394a90ae17b",
"productndc": "70518-4515",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090162",
"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": "Feb 19, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090162",
"marketing_category": "ANDA",
"nonproprietary_name": "topiramate",
"start_marketing_date": "20251104",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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