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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LACOSAMIDELACOSAMIDEPrecision Dose, Inc.fe24b28b-ca15-4dfd-a198-53cdc2c8cb992025-03-31Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEAmerican Health Packagingf9aa6154-5d80-4597-90c3-cec131b455d42025-03-26Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDECoupler LLC2d999f1f-11c6-bc28-e063-6394a90a4a522025-02-20Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
Lacosamide Oral SolutionLACOSAMIDEChartwell RX, LLC7197c0b6-5bb9-43b3-be1d-e7615629df9a2025-02-12Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEFlorida Pharmaceutical Products, LLC3680c0ff-7f5c-4572-b1eb-4fea96b7fbe22025-02-12Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEFresenius Kabi USA, LLC419ff519-2b19-4fb9-adfa-868ba02294072025-02-05Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEGolden State Medical Supply, Inc.f047077c-2ac7-30d0-e053-2995a90ae4292025-01-27Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDENovadoz Pharmaceuticals LLCa024081a-e131-4e88-967d-40155651a9452024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDEMarlex Pharmaceuticals, Inc0a273024-c2d2-4fae-90c3-b2f38a323f242024-12-15Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDELeading Pharma, LLC45786c84-51ef-4440-bc88-2501951e4c412024-12-06Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDETrigen Laboratories, LLCd98ec7ed-353f-4d4f-9ccd-57ddc62edd0d2024-11-20Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDESomerset Therapeutics, LLC00203a7b-e774-45f7-ac6b-48db6d32a48a2024-10-16Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDESun Pharmaceutical Industries, Inc.2098d3a5-776e-4b52-8ade-80a3ab7b3de72024-10-14Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEUnichem Pharmaceuticals (USA), Inc.7ed5cebe-470e-48a4-86ec-2ce79cc326882024-09-17Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEBreckenridge Pharmaceutical, Inc.f7ea3ce6-4ca7-4405-a011-48e7d71360a52024-09-12Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDENorthStar RxLLCe969b294-48d9-42a2-a093-0ac7151424602024-08-05Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDEMajor Pharmaceuticals973cea8d-e516-4014-a116-c5990554a5502024-07-22Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEMacleods Pharmaceuticals Limited035d85e5-8688-4390-bd55-74baa91c0e9d2024-06-04Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEPAI Holdings, LLC dba PAI Pharma75de00d8-d2e7-4025-be4e-f49299068e7e2024-05-30Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEAmneal Pharmaceuticals of New York LLC0e21389b-2f51-4975-aa21-fc5c9dd9f6dc2024-05-17Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5

Reported adverse events (FAERS/openFDA)#

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