lacosamide

Generic: lacosamide

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler indoco remedies limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-406
Product ID 14445-406_080b7b57-d72a-4306-993e-81ac0278ab5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214301
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14445406
Hyphenated Format 14445-406

Supplemental Identifiers

RxCUI
809974
UPC
0314445406205
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 ANDA214301 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (14445-406-20) / 20 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

14445-406-20 10 VIAL, GLASS in 1 CARTON (14445-406-20) / 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": "080b7b57-d72a-4306-993e-81ac0278ab5d", "openfda": {"nui": ["N0000008486"], "upc": ["0314445406205"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["ba337b2c-7c1f-4f7b-ba93-054f502400f3"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (14445-406-20)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "14445-406-20", "marketing_start_date": "20220409"}], "brand_name": "Lacosamide", "product_id": "14445-406_080b7b57-d72a-4306-993e-81ac0278ab5d", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "14445-406", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA214301", "marketing_category": "ANDA", "marketing_start_date": "20220409", "listing_expiration_date": "20261231"}