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United States · US · US:68094-076_ecaaaf34-a01b-4160-951b-47f72c4b5d9e
LACOSAMIDE
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrecision Dose, Inc.
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168094076623 TRAY in 1 CASE (68094-076-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-076-59)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A216461
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": "68094-076_ecaaaf34-a01b-4160-951b-47f72c4b5d9e",
"productndc": "68094-076",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216461",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Feb 6, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "LACOSAMIDE",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA216461",
"marketing_category": "ANDA",
"nonproprietary_name": "LACOSAMIDE",
"start_marketing_date": "20250922",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX18.
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