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United States · US · US:70518-1937_52545d27-d278-1910-e063-6394a90a449a
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 · 5
- ndc11705181937030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1937-0)
- ndc117051819373100 POUCH in 1 BOX (70518-1937-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1937-4)
- ndc117051819375120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1937-5)
- ndc117051819376180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1937-6)
- ndc117051819377120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1937-7)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A078235
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": "70518-1937_52545d27-d278-1910-e063-6394a90a449a",
"productndc": "70518-1937",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078235",
"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": "ANDA078235",
"marketing_category": "ANDA",
"nonproprietary_name": "topiramate",
"start_marketing_date": "20190306",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX11.
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