lacosamide

Generic: lacosamide

Labeler: sintetica us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler sintetica us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Sintetica US LLC

Identifiers & Regulatory

Product NDC 83090-012
Product ID 83090-012_d122b8ed-0688-4516-92a2-4b1fa1e7fa99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217311
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2024-03-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83090012
Hyphenated Format 83090-012

Supplemental Identifiers

RxCUI
809974
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 ANDA217311 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

83090-012-10 10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS

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": ["INTRAVENOUS"], "spl_id": "d122b8ed-0688-4516-92a2-4b1fa1e7fa99", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["08ac486a-4f61-4e9e-9683-d1a66a6c2a4d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Sintetica US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (83090-012-10)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "83090-012-10", "marketing_start_date": "20240315"}], "brand_name": "Lacosamide", "product_id": "83090-012_d122b8ed-0688-4516-92a2-4b1fa1e7fa99", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "83090-012", "dea_schedule": "CV", "generic_name": "lacosamide", "labeler_name": "Sintetica US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA217311", "marketing_category": "ANDA", "marketing_start_date": "20240315", "listing_expiration_date": "20271231"}