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United States · US · US:68382-005_69df5f84-1db1-4eb2-ae32-462137a4d812
topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838200501100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-01)
- ndc116838200505500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-05)
- ndc1168382005101000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-10)
- ndc11683820051460 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-14)
- ndc11683820051690 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-16)
- ndc11683820051728 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-17)
Annotations
UNII (FDA Substance ID)
0H73WJJ391
TOPIRAMATE
RxCUI 38404
Orange Book
A078877
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": "68382-005_69df5f84-1db1-4eb2-ae32-462137a4d812",
"productndc": "68382-005",
"dosage_form": "CAPSULE, COATED PELLETS",
"orange_book": {
"appl_no": "078877",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Oct 14, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Oct 14, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Oct 23, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078877",
"marketing_category": "ANDA",
"nonproprietary_name": "topiramate",
"start_marketing_date": "20091014",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N03AX11.
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