lacosamide

Generic: lacosamide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-918
Product ID 47335-918_506a57ae-8168-44b2-88ef-b9f0e4d0c6b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205031
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335918
Hyphenated Format 47335-918

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0347335943863 0347335980868
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 ANDA205031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-918-18)
  • 180 TABLET, FILM COATED in 1 BOTTLE (47335-918-82)
  • 60 TABLET, FILM COATED in 1 BOTTLE (47335-918-86)
source: ndc

Packages (3)

47335-918-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-918-18) 47335-918-82 180 TABLET, FILM COATED in 1 BOTTLE (47335-918-82) 47335-918-86 60 TABLET, FILM COATED in 1 BOTTLE (47335-918-86)

Ingredients (1)

lacosamide (50 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": "506a57ae-8168-44b2-88ef-b9f0e4d0c6b9", "openfda": {"nui": ["N0000008486"], "upc": ["0347335943863", "0347335980868"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["2098d3a5-776e-4b52-8ade-80a3ab7b3de7"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-918-18)", "package_ndc": "47335-918-18", "marketing_start_date": "20220319"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (47335-918-82)", "package_ndc": "47335-918-82", "marketing_start_date": "20220319"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (47335-918-86)", "package_ndc": "47335-918-86", "marketing_start_date": "20220319"}], "brand_name": "Lacosamide", "product_id": "47335-918_506a57ae-8168-44b2-88ef-b9f0e4d0c6b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "47335-918", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA205031", "marketing_category": "ANDA", "marketing_start_date": "20220319", "listing_expiration_date": "20261231"}