Lacosamide

Product NDC: 59651-016
11-digit product format: 596510016
Labeler code: 59651
Product ID: 59651-016_3b9722c2-c742-4617-9832-672dd8a3ce0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lacosamide
Dosage form: SOLUTION
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA209224
Marketing category: ANDA
Marketing start: 2024-01-24
Substance: LACOSAMIDE
Active strength: 10 mg/mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
LACOSAMIDE	10 mg/mL

Field, Values table
Field	Values
Unii	563KS2PQY5
Rxcui	993856

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac83aa9-21ef-4152-b501-369c0bc4765b	Product name	1	20231010
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
c8c500b5-16db-e0e3-fdf1-c683d7be70e3	Product name	3	20161117
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-016-02	Lacosamide	200 mL in 1 BOTTLE, PLASTIC	SOLUTION	200		3
59651-016-46	Lacosamide	465 mL in 1 BOTTLE, PLASTIC	SOLUTION	465		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-016-02	ML - Milliliter	59651-016	d1a3d0e8-023a-47d6-b9ef-503f84f1c3cf	1	2024-03-12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-016	LACOSAMIDE SOLUTION [AUROBINDO PHARMA LIMITED]	2	Current NDC, 2 package rows	20241019_614490ce-a62c-4222-8e4b-ce802cf63028.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
563KS2PQY5	LACOSAMIDE	175481-36-4	LACOSAMIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993856	lacosamide 10 MG in 1 mL Oral Solution	PSN	614490ce-a62c-4222-8e4b-ce802cf63028	3
993856	lacosamide 10 MG/ML Oral Solution	SCD	614490ce-a62c-4222-8e4b-ce802cf63028	3
993856	lacosamide 10 MG per 1 ML Oral Solution	SY	614490ce-a62c-4222-8e4b-ce802cf63028	3
993856	lacosamide 10 MG in 1 mL Oral Solution	PSN	f9aa6154-5d80-4597-90c3-cec131b455d4	2
993856	lacosamide 10 MG/ML Oral Solution	SCD	f9aa6154-5d80-4597-90c3-cec131b455d4	2
993856	lacosamide 10 MG per 1 ML Oral Solution	SY	f9aa6154-5d80-4597-90c3-cec131b455d4	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59651-016-02	59651001602	200 mL in 1 BOTTLE, PLASTIC (59651-016-02)	200 ml	2024-01-24	No	No	Historical
59651-016-46	59651001646	465 mL in 1 BOTTLE, PLASTIC (59651-016-46)	465 ml	2024-01-24	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lacosamide	Aurobindo Pharma Limited	2026-04-15	Human Prescription Drug Label	3
Lacosamide	American Health Packaging	2025-03-26	HUMAN PRESCRIPTION DRUG LABEL	2