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United States · US · US:62135-885_2df7ee04-2970-8b37-e063-6294a90a29a4
Lacosamide Oral Solution
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116213588522200 mL in 1 BOTTLE (62135-885-22)
- ndc1162135885232 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10)
- ndc1162135885242 TRAY in 1 BOX (62135-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A215154
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": "62135-885_2df7ee04-2970-8b37-e063-6294a90a29a4",
"productndc": "62135-885",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "215154",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "May 15, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "Lacosamide Oral Solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215154",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20240515",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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