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United States · US · US:65841-651_c45924d5-c45b-4f31-afa5-0cbc090d2816
topiramate
Orange BookUNIISPLATC N03AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN03AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116584165101100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-651-01)
- ndc116584165105500 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-651-05)
- ndc1165841651101000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-651-10)
- ndc11658416511460 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-651-14)
- ndc11658416511690 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-651-16)
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": "65841-651_c45924d5-c45b-4f31-afa5-0cbc090d2816",
"productndc": "65841-651",
"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": "15"
}Related drugs
Other records sharing ATC code N03AX11.
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