Label: LACOSAMIDE injection
- NDC Code(s): 70771-1682-1, 70771-1682-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated October 3, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LACOSAMIDE
lacosamide injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1682 Route of Administration INTRAVENOUS DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5) LACOSAMIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1682-6 10 in 1 CARTON 06/29/2022 1 NDC:70771-1682-1 20 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209465 06/29/2022 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1682) , ANALYSIS(70771-1682)