LACOSAMIDE- lacosamide injection 
Zydus Lifesciences Limited

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LACOSAMIDE injection, for intravenous use, CV

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1682-1

Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

For Intravenous Use Only

20 mL single-dose vial

Rx only

vial label

NDC 70771-1682-6

Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

For Intravenous Use Only

10 X 20 mL Single-dose vials

Rx only

carton label
LACOSAMIDE 
lacosamide injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1682
Route of AdministrationINTRAVENOUSDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5) LACOSAMIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1682-610 in 1 CARTON06/29/2022
1NDC:70771-1682-120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20946506/29/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1682) , ANALYSIS(70771-1682)

Revised: 10/2023
Document Id: 96b87696-5bfd-4306-b00e-c66e7b93f071
Set id: 3bc84c70-bc1d-4a72-bbe7-86f32cd646d0
Version: 2
Effective Time: 20231003
 
Zydus Lifesciences Limited