lacosamide

Generic: lacosamide

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-791
Product ID 25021-791_3cabc3ea-4c98-462e-ae04-ccc0ab25c7a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214301
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021791
Hyphenated Format 25021-791

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 ANDA214301 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (25021-791-20) / 20 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

25021-791-20 10 VIAL, GLASS in 1 CARTON (25021-791-20) / 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": "3cabc3ea-4c98-462e-ae04-ccc0ab25c7a7", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["6b4536d0-5703-42b0-9f59-46a3e1b75b22"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (25021-791-20)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "25021-791-20", "marketing_start_date": "20220317"}], "brand_name": "LACOSAMIDE", "product_id": "25021-791_3cabc3ea-4c98-462e-ae04-ccc0ab25c7a7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "25021-791", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "Sagent Pharmaceuticals", "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": "20220317", "listing_expiration_date": "20261231"}