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United States · US · US:51991-351_d59d1657-c847-475f-998d-49d186f6697e
LACOSAMIDE
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBreckenridge Pharmaceutical, Inc.
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115199135105500 TABLET, FILM COATED in 1 BOTTLE (51991-351-05)
- ndc11519913510660 TABLET, FILM COATED in 1 BOTTLE (51991-351-06)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A204921
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "563KS2PQY5",
"rxcui": "623400",
"inchikey": "VPPJLAIAVCUEMN-GFCCVEGCSA-N",
"display_name": "LACOSAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b4": {
"match": "brand_token",
"title": "LACOSAMIDE INJECTION [DR. REDDY'S LABORATORIES INC.]",
"spl_version": "8",
"published_date": "2026-05-28"
}
},
"productid": "51991-351_d59d1657-c847-475f-998d-49d186f6697e",
"productndc": "51991-351",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204921",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Mar 17, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Mar 17, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Mar 17, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Mar 17, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "LACOSAMIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204921",
"marketing_category": "ANDA",
"nonproprietary_name": "LACOSAMIDE",
"start_marketing_date": "20220318",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AX18.
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