lacosamide

Generic: lacosamide

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

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 200 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-174
Product ID 46708-174_7dafef1c-ba47-4562-aaa5-671105136aa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204974
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-03-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708174
Hyphenated Format 46708-174

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 ANDA204974 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 CARTON (46708-174-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-174-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (46708-174-60)
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-174-71)
source: ndc

Packages (4)

46708-174-10 100 TABLET, FILM COATED in 1 CARTON (46708-174-10) 46708-174-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-174-30) 46708-174-60 60 TABLET, FILM COATED in 1 BOTTLE (46708-174-60) 46708-174-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-174-71)

Ingredients (1)

lacosamide (200 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": "7dafef1c-ba47-4562-aaa5-671105136aa6", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["46b98d5e-fdb6-483a-b022-8b1f0aa832c5"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (46708-174-10)", "package_ndc": "46708-174-10", "marketing_start_date": "20220318"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-174-30)", "package_ndc": "46708-174-30", "marketing_start_date": "20220318"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (46708-174-60)", "package_ndc": "46708-174-60", "marketing_start_date": "20220318"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-174-71)", "package_ndc": "46708-174-71", "marketing_start_date": "20220318"}], "brand_name": "Lacosamide", "product_id": "46708-174_7dafef1c-ba47-4562-aaa5-671105136aa6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "46708-174", "dea_schedule": "CV", "generic_name": "lacosamide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA204974", "marketing_category": "ANDA", "marketing_start_date": "20220318", "listing_expiration_date": "20261231"}