lacosamide

Generic: lacosamide

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler novadoz pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-034
Product ID 72205-034_4e47a51d-1af3-4e8d-b45b-0c1c3ca0f4d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215379
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-12-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205034
Hyphenated Format 72205-034

Supplemental Identifiers

RxCUI
993856
UPC
0372205034464 0372205034754 0372205034747 0372205034440 0372205034471 0372205034457
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 ANDA215379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 TRAY in 1 BOX (72205-034-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (72205-034-44)
  • 200 mL in 1 BOTTLE, PLASTIC (72205-034-74)
  • 465 mL in 1 BOTTLE, PLASTIC (72205-034-75)
  • 1 TRAY in 1 BOX (72205-034-91) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (72205-034-45)
  • 1 TRAY in 1 BOX (72205-034-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (72205-034-46)
  • 1 TRAY in 1 BOX (72205-034-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (72205-034-47)
source: ndc

Packages (6)

72205-034-50 1 TRAY in 1 BOX (72205-034-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (72205-034-44) 72205-034-74 200 mL in 1 BOTTLE, PLASTIC (72205-034-74) 72205-034-75 465 mL in 1 BOTTLE, PLASTIC (72205-034-75) 72205-034-91 1 TRAY in 1 BOX (72205-034-91) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (72205-034-45) 72205-034-93 1 TRAY in 1 BOX (72205-034-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (72205-034-46) 72205-034-94 1 TRAY in 1 BOX (72205-034-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (72205-034-47)

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": ["ORAL"], "spl_id": "4e47a51d-1af3-4e8d-b45b-0c1c3ca0f4d0", "openfda": {"nui": ["N0000008486"], "upc": ["0372205034464", "0372205034754", "0372205034747", "0372205034440", "0372205034471", "0372205034457"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["b9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 BOX (72205-034-50)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (72205-034-44)", "package_ndc": "72205-034-50", "marketing_start_date": "20241212"}, {"sample": false, "description": "200 mL in 1 BOTTLE, PLASTIC (72205-034-74)", "package_ndc": "72205-034-74", "marketing_start_date": "20231229"}, {"sample": false, "description": "465 mL in 1 BOTTLE, PLASTIC (72205-034-75)", "package_ndc": "72205-034-75", "marketing_start_date": "20231229"}, {"sample": false, "description": "1 TRAY in 1 BOX (72205-034-91)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (72205-034-45)", "package_ndc": "72205-034-91", "marketing_start_date": "20241212"}, {"sample": false, "description": "1 TRAY in 1 BOX (72205-034-93)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (72205-034-46)", "package_ndc": "72205-034-93", "marketing_start_date": "20241212"}, {"sample": false, "description": "1 TRAY in 1 BOX (72205-034-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (72205-034-47)", "package_ndc": "72205-034-94", "marketing_start_date": "20241212"}], "brand_name": "Lacosamide", "product_id": "72205-034_4e47a51d-1af3-4e8d-b45b-0c1c3ca0f4d0", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72205-034", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA215379", "marketing_category": "ANDA", "marketing_start_date": "20231222", "listing_expiration_date": "20261231"}