Lacosamide

Product NDC
82804-993
11-digit product format
828040993
Labeler code
82804
Product ID
82804-993_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205237
Marketing category
ANDA
Marketing start
2023-07-10
Substance
LACOSAMIDE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
563KS2PQY5LACOSAMIDE175481-36-4LACOSAMIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-993-0082804099300100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-00) 2024-05-21NoNoHistorical
82804-993-11828040993111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-11) 2024-05-21NoNoHistorical
82804-993-308280409933030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-30) 2024-05-21NoNoHistorical
82804-993-5582804099355500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-55) 2024-05-21NoNoHistorical
82804-993-608280409936060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-60) 2024-05-21NoNoHistorical
82804-993-6482804099364240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-64) 2024-05-21NoNoHistorical
82804-993-7282804099372120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-72) 2024-05-21NoNoHistorical
82804-993-7882804099378180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-78) 2024-05-21NoNoHistorical
82804-993-908280409939090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-90) 2024-05-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LacosamideProficient Rx LP2024-05-01HUMAN PRESCRIPTION DRUG LABEL1