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 1 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lacosamide Oral SolutionLACOSAMIDEAvKARE5b10986e-0809-b6d1-e063-6394a90a57382026-09-09Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDENovadoz Pharmaceuticals LLCb9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b2026-08-12Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEWestminster Pharmaceuticals, LLCecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb862026-08-11Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEGlenmark Pharmaceuticals Limited458e80da-8fc1-4715-9b4b-bc4f388f933f2026-08-11Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEREMEDYREPACK INC.edd20b60-6265-4c4e-a95a-aaf8103cd8522026-07-21Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEFosun Pharma USAec1c5ddb-1143-7e6a-e053-2995a90a83822026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDEGland Pharma Limited779d2381-f590-45f9-a191-f44af821f4c82026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDEAurobindo Pharma Limited6140b3f1-ff60-427c-91d7-15af99fd78f12026-06-29Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEAurobindo Pharma Limited614490ce-a62c-4222-8e4b-ce802cf630282026-06-22Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.c5b91128-f838-4e98-9684-5f477fc7af062026-06-22Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEZydus Pharmaceuticals USA Inc.16a9afd2-35a6-44a9-b1d9-ca195c8640d72026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDEMajor Pharmaceuticalsc83d2156-4dde-4316-98f1-b3dc751f3eac2026-06-09Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDENorthStar Rx LLC48fcaa27-baaa-446e-a282-0c3e232cd1512026-05-28Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEDr. Reddy's Laboratories Inc.cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b42026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
VimpatLACOSAMIDEUCB, Inc.9e79b42c-38a3-4b2c-a196-a5a1948250e22026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEZydus Pharmaceuticals USA Inc.07356cf2-224b-40d2-b827-e10a6b42c2322026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDEBryant Ranch Prepack024bca92-cac5-4832-a1ff-c1b3d5994ba02026-05-06Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.e24d3c45-a559-4fca-a7be-74ce37a7066e2026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEClinical Solutions Wholesale, LLC264c3718-67ea-4483-b036-2514c853635a2026-03-24Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEAmerican Health Packaging19060029-c158-4a37-9261-cfe3b2b5b1e32026-03-06Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5

Reported adverse events (FAERS/openFDA)#

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