lacosamide

Generic: lacosamide

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lacosamide 100 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-924
Product ID 53746-924_9ae72ba8-4a6b-4d01-b73e-0f1c9ae18711
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204857
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-05-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746924
Hyphenated Format 53746-924

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
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 ANDA204857 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (53746-924-05)
  • 60 TABLET in 1 BOTTLE (53746-924-60)
source: ndc

Packages (2)

53746-924-05 500 TABLET in 1 BOTTLE (53746-924-05) 53746-924-60 60 TABLET in 1 BOTTLE (53746-924-60)

Ingredients (1)

lacosamide (100 mg/1)

Linked Drug Pages (1)

Lacosamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9ae72ba8-4a6b-4d01-b73e-0f1c9ae18711", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["0e21389b-2f51-4975-aa21-fc5c9dd9f6dc"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-924-05)", "package_ndc": "53746-924-05", "marketing_start_date": "20230517"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (53746-924-60)", "package_ndc": "53746-924-60", "marketing_start_date": "20230517"}], "brand_name": "Lacosamide", "product_id": "53746-924_9ae72ba8-4a6b-4d01-b73e-0f1c9ae18711", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "53746-924", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA204857", "marketing_category": "ANDA", "marketing_start_date": "20230517", "listing_expiration_date": "20261231"}