lacosamide

Generic: lacosamide

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lacosamide 50 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-548
Product ID 16714-548_ad8753cb-70b7-431e-9d52-93558d469ef5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208308
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714548
Hyphenated Format 16714-548

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0316714548012 0316714550015 0316714552019 0316714549019
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 ANDA208308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (16714-548-01)
source: ndc

Packages (1)

16714-548-01 60 TABLET in 1 BOTTLE (16714-548-01)

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": "ad8753cb-70b7-431e-9d52-93558d469ef5", "openfda": {"nui": ["N0000008486"], "upc": ["0316714548012", "0316714550015", "0316714552019", "0316714549019"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["9dffda6c-9e44-478f-9e02-9da3ab4c50e1"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (16714-548-01)", "package_ndc": "16714-548-01", "marketing_start_date": "20220801"}], "brand_name": "Lacosamide", "product_id": "16714-548_ad8753cb-70b7-431e-9d52-93558d469ef5", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "16714-548", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA208308", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}