FDA.reportPublic FDA data

NDC 83854-002-01 - LACOSAMIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
83854-002
Requested NDC
83854-002-01
Package NDCs from labels
83854-002-01, 83854-002-10
Manufacturer
Anthea Pharma Private Limited
Effective date
2026-01-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LACOSAMIDE - Anthea Pharma Private LimitedAnthea Pharma Private Limited2026-01-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83854-002-01LACOSAMIDE20 mL in 1 VIALINJECTION, SOLUTION205
83854-002-10LACOSAMIDE10 in 1 CARTONINJECTION, SOLUTION105

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lacosamide Oral SolutionLACOSAMIDEChartwell Governmental & Specialty RX, LLC.e265fd09-8149-4423-a317-5760d34b8e9b2026-02-25Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
Lacosamide Oral SolutionLACOSAMIDE ORALFlorida Pharmaceutical Products, LLCba4e2e28-7dc3-47b3-9c2c-34e0b1f39fb82026-02-12Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEKanchan Healthcare Inc41f02424-231d-4039-a122-df4b49dc99982026-01-29Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEAnthea Pharma Private Limitedb4f2620a-2047-4b33-bb75-18702f6c55e62026-01-24Warnings, Adverse reactionsExact identifier
application number: ANDA220268
ndc (package): 83854-002-01
ndc (package): 83854-002-10
ndc (product): 83854-002
ndc11 (package): 83854000201
rxcui: 809974
spl id: 491d8945-109a-8c82-e063-6394a90a7a04
spl set id: b4f2620a-2047-4b33-bb75-18702f6c55e6
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEGLENMARK PHARMACEUTICALS INC., USAbc7ed8a6-acce-48f2-9ef1-4e366c71dbbc2026-01-24Warnings, Adverse reactionsExact identifier
application number: ANDA220268
rxcui: 809974
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEVirtus Pharmaceuticals, LLC01162e2f-967b-4596-8188-c0d9889c38142026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDESintetica US LLC08ac486a-4f61-4e9e-9683-d1a66a6c2a4d2026-01-04Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
Lacosamide Oral SolutionLACOSAMIDEAjenat Pharmaceuticals LLCcb29da34-89aa-405a-8fbc-2308bda371872025-12-29Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
lacosamideLACOSAMIDEGlenmark Pharmaceuticals Inc. USAdf1d2e6a-6129-49c9-b2c1-0fdf73f38b9c2025-12-17Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
Lacosamide Oral SolutionLACOSAMIDEKesin Pharma Corporation446f14be-5d79-26b9-e063-6294a90ae0b52025-11-25Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEKanchan Healthcare Inc5c03b90e-6985-4005-b6c5-44626d0600d72025-10-19Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
Lacosamide Oral SolutionLACOSAMIDE ORAL SOLUTIONAscend Laboratories, LLC4ae87834-05d8-43c8-aaa3-78047d4a573c2025-10-09Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDENorthStar RxLLC9dffda6c-9e44-478f-9e02-9da3ab4c50e12025-10-05Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDECamber Pharmaceuticals, Inc.bbd80370-3d23-41f8-8914-c6ea897c01542025-09-29Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEAscend Laboratories, LLC9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de2025-08-11Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
Lacosamide Oral SolutionLACOSAMIDEKesin Pharmaceutical Corporation3ba29442-4e8a-c2b2-e063-6294a90a1bbf2025-08-05Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEWestminster Pharmaceuticals, LLC61e3747a-3957-4840-81f0-313aefbd5d2b2025-07-29Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
MOTPOLY XRLACOSAMIDEAucta Pharmaceuticals, Inc.fb8235b4-4cd3-6f22-e053-6294a90a545c2025-07-16Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEANI Pharmaceuticals, Inc.68033c90-d9cc-4d5f-896c-9a61a0c3b5292025-06-25Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEAdvanced Rx of Tennessee, LLC325df1b7-4908-0c03-e063-6294a90ad8442025-04-09Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.