lacosamide

Generic: lacosamide

Labeler: glenmark pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler glenmark pharmaceuticals limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Glenmark Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 68462-940
Product ID 68462-940_887e8e82-ff05-445b-aaa3-d9fe1590a258
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215379
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2024-09-30

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462940
Hyphenated Format 68462-940

Supplemental Identifiers

RxCUI
993856
UPC
0368462940860
UNII
563KS2PQY5
NUI
N0000008486

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lacosamide (source: ndc)
Generic Name lacosamide (source: ndc)
Application Number ANDA215379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 200 mL in 1 BOTTLE, PLASTIC (68462-940-86)
source: ndc

Packages (1)

68462-940-86 200 mL in 1 BOTTLE, PLASTIC (68462-940-86)

Ingredients (1)

lacosamide (10 mg/mL)

Linked Drug Pages (1)

Lacosamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "887e8e82-ff05-445b-aaa3-d9fe1590a258", "openfda": {"nui": ["N0000008486"], "upc": ["0368462940860"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["458e80da-8fc1-4715-9b4b-bc4f388f933f"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Glenmark Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE, PLASTIC (68462-940-86)", "package_ndc": "68462-940-86", "marketing_start_date": "20240930"}], "brand_name": "Lacosamide", "product_id": "68462-940_887e8e82-ff05-445b-aaa3-d9fe1590a258", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68462-940", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Glenmark Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA215379", "marketing_category": "ANDA", "marketing_start_date": "20240930", "listing_expiration_date": "20271231"}