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United States · US · US:52652-9001_3feb6452-372c-4c60-8e91-220be75f90b1
Eprontia
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115265290011473 mL in 1 BOTTLE (52652-9001-1)
- ndc1152652900121 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE
- ndc1152652900131 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
N214679
AB
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": {
"e2a4df59-fead-4a01-9021-9eda02c48010": {
"match": "brand_token",
"title": "EPRONTIA (TOPIRAMATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2026-03-23"
}
},
"productid": "52652-9001_3feb6452-372c-4c60-8e91-220be75f90b1",
"productndc": "52652-9001",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "214679",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "25MG/ML",
"product_no": "001",
"approval_date": "Nov 5, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Eprontia",
"active_ingred_unit": "mg/mL",
"application_number": "NDA214679",
"marketing_category": "NDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20211206",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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