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United States · US · US:43485-102_890ef534-7363-4f2b-b125-8f62e2eb26d0
Spritam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAprecia Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1143485102036 BLISTER PACK in 1 CARTON (43485-102-03) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01)
- ndc11434851026060 BLISTER PACK in 1 CARTON (43485-102-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
N207958
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": {
"be651c31-383f-11e4-916c-0800200c9a66": {
"match": "brand_token",
"title": "SPRITAM (LEVETIRACETAM) TABLET, FOR SUSPENSION [APRECIA PHARMACEUTICALS, LLC]",
"spl_version": "29",
"published_date": "2025-11-17"
}
},
"productid": "43485-102_890ef534-7363-4f2b-b125-8f62e2eb26d0",
"productndc": "43485-102",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "207958",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "250MG",
"product_no": "001",
"approval_date": "Jul 31, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG",
"product_no": "002",
"approval_date": "Jul 31, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "750MG",
"product_no": "003",
"approval_date": "Jul 31, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "1GM",
"product_no": "004",
"approval_date": "Jul 31, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Spritam",
"active_ingred_unit": "mg/1",
"application_number": "NDA207958",
"marketing_category": "NDA",
"nonproprietary_name": "levetiracetam",
"start_marketing_date": "20160205",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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