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United States · US · US:59651-016_3b9722c2-c742-4617-9832-672dd8a3ce0e
Lacosamide
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115965101602200 mL in 1 BOTTLE, PLASTIC (59651-016-02)
- ndc115965101646465 mL in 1 BOTTLE, PLASTIC (59651-016-46)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A209224
AA
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": "59651-016_3b9722c2-c742-4617-9832-672dd8a3ce0e",
"productndc": "59651-016",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "209224",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Jan 24, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "Lacosamide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209224",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20240124",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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