lacosamide oral solution (68999-885)

Drug Facts

Product Profile

Brand Name lacosamide oral solution

Generic Name lacosamide

Labeler chartwell governmental & specialty rx, llc.

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

lacosamide 10 mg/mL

Manufacturer

Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-885

Product ID 68999-885_4ba97913-d84d-a2c3-e063-6394a90a2363

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215154

DEA Schedule cv

Listing Expiration 2027-12-31

Marketing Start 2024-05-15

Pharmacologic Class

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68999885

Hyphenated Format 68999-885

Supplemental Identifiers

RxCUI

993856

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 oral solution (source: ndc)

Generic Name lacosamide (source: ndc)

Application Number ANDA215154 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

2 TRAY in 1 BOX (68999-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-885-10)
2 TRAY in 1 BOX (68999-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-885-05)

source: ndc

Packages (2)

68999-885-23 2 TRAY in 1 BOX (68999-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-885-10) 68999-885-24 2 TRAY in 1 BOX (68999-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-885-05)

Ingredients (1)

lacosamide (10 mg/mL)

Linked Drug Pages (1)

Lacosamide Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4ba97913-d84d-a2c3-e063-6394a90a2363", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["e265fd09-8149-4423-a317-5760d34b8e9b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-885-23)  / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-885-10)", "package_ndc": "68999-885-23", "marketing_start_date": "20260114"}, {"sample": false, "description": "2 TRAY in 1 BOX (68999-885-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-885-05)", "package_ndc": "68999-885-24", "marketing_start_date": "20260114"}], "brand_name": "Lacosamide Oral Solution", "product_id": "68999-885_4ba97913-d84d-a2c3-e063-6394a90a2363", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68999-885", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide Oral Solution", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA215154", "marketing_category": "ANDA", "marketing_start_date": "20240515", "listing_expiration_date": "20271231"}