lacosamide

Generic: lacosamide

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler precision dose, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 100 mg/10mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-176
Product ID 68094-176_ecaaaf34-a01b-4160-951b-47f72c4b5d9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216461
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-09-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094176
Hyphenated Format 68094-176

Supplemental Identifiers

RxCUI
993856
UNII
563KS2PQY5
NUI
N0000008486

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 ANDA216461 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (68094-176-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-176-59)
source: ndc

Packages (1)

68094-176-62 3 TRAY in 1 CASE (68094-176-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-176-59)

Ingredients (1)

lacosamide (100 mg/10mL)

Linked Drug Pages (1)

LACOSAMIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ecaaaf34-a01b-4160-951b-47f72c4b5d9e", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["fe24b28b-ca15-4dfd-a198-53cdc2c8cb99"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (68094-176-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-176-59)", "package_ndc": "68094-176-62", "marketing_start_date": "20250922"}], "brand_name": "LACOSAMIDE", "product_id": "68094-176_ecaaaf34-a01b-4160-951b-47f72c4b5d9e", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68094-176", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACOSAMIDE", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/10mL"}], "application_number": "ANDA216461", "marketing_category": "ANDA", "marketing_start_date": "20250922", "listing_expiration_date": "20261231"}