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United States · US · US:70771-1682_96b87696-5bfd-4306-b00e-c66e7b93f071
LACOSAMIDE
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11707711682610 VIAL in 1 CARTON (70771-1682-6) / 20 mL in 1 VIAL (70771-1682-1)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A209465
AP
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": "INTRAVENOUS",
"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": "70771-1682_96b87696-5bfd-4306-b00e-c66e7b93f071",
"productndc": "70771-1682",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "209465",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/20ML (10MG/ML)",
"product_no": "001",
"approval_date": "Jun 29, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "LACOSAMIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209465",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20220629",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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