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United States · US · US:59212-681_e3848741-066e-4ee2-bf13-0b4c1d32b3c2
Zonegran
Orange BookUNIISPLATC N03AX15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeN03AX15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115921268110100 CAPSULE in 1 BOTTLE (59212-681-10)
Annotations
UNII (FDA Substance ID)
459384H98V
ZONISAMIDE
RxCUI 39998
Orange Book
N020789
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "459384H98V",
"rxcui": "39998",
"inchikey": "UBQNRHZMVUUOMG-UHFFFAOYSA-N",
"display_name": "ZONISAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d12de43e-3ac3-4335-bc85-70d7366a91eb": {
"match": "brand_token",
"title": "ZONEGRAN (ZONISAMIDE) CAPSULE [ADVANZ PHARMA (US) CORP.]",
"spl_version": "12",
"published_date": "2025-10-03"
}
},
"productid": "59212-681_e3848741-066e-4ee2-bf13-0b4c1d32b3c2",
"productndc": "59212-681",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020789",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 27, 2000"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Aug 22, 2003"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Aug 22, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZONISAMIDE",
"proprietary_name": "Zonegran",
"active_ingred_unit": "mg/1",
"application_number": "NDA020789",
"marketing_category": "NDA",
"nonproprietary_name": "Zonisamide",
"start_marketing_date": "20000327",
"active_numerator_strength": "25"
}Related drugs
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