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United States · US · US:63629-9847_cac0490d-b164-41d1-81f9-336c8cf1b5b9
LEVETIRACETAM
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11636299847121 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9847-1)
- ndc11636299847230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9847-2)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A203468
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "44YRR34555",
"rxcui": "114477",
"inchikey": "HPHUVLMMVZITSG-LURJTMIESA-N",
"display_name": "LEVETIRACETAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"52fa0eec-3dd9-59ca-e063-6394a90a9791": {
"match": "brand_token",
"title": "LEVETIRACETAM TABLET, FILM COATED [INJECTA MEDCIAL LLC]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "63629-9847_cac0490d-b164-41d1-81f9-336c8cf1b5b9",
"productndc": "63629-9847",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "203468",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "May 21, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "002",
"approval_date": "May 21, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "LEVETIRACETAM",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203468",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVETIRACETAM",
"start_marketing_date": "20140501",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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