FDA.reportPublic FDA data

NDC 68462-697-20 - 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
68462-697
Requested NDC
68462-697-20
Package NDCs from labels
68462-697-20, 68462-697-30
Manufacturer
GLENMARK PHARMACEUTICALS INC., USA | 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 - GLENMARK PHARMACEUTICALS INC., USA | Anthea Pharma Private LimitedGLENMARK PHARMACEUTICALS INC., USA | Anthea Pharma Private Limited2026-01-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-697-20LACOSAMIDE20 mL in 1 VIALINJECTION, SOLUTION201
68462-697-30LACOSAMIDE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-697-20ML - Milliliter68462-697472808b0-44a4-4780-82fa-257ac434d77412026-04-20
68462-697-30ML - Milliliter68462-69715ef1877-849d-4017-b340-1a6c1313697512026-04-20

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 4 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LacosamideLACOSAMIDEProficient Rx LP47ae2f1f-d135-4f4e-acc2-500c1afa7b8b2024-05-01Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEIndoco Remedies Limitedba337b2c-7c1f-4f7b-ba93-054f502400f32024-03-26Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDEAlembic Pharmaceuticals Inc.07b7b3f2-16a0-4deb-883b-10522676d9662023-11-09Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEZydus Lifesciences Limited3bc84c70-bc1d-4a72-bbe7-86f32cd646d02023-10-03Exact identifier
rxcui: 809974
unii: 563KS2PQY5
LacosamideLACOSAMIDETris Pharma Inc7f37f8b8-07d3-48c4-a0c4-7652b62a1ad92023-06-26Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEAlembic Pharmaceuticals Limited46b98d5e-fdb6-483a-b022-8b1f0aa832c52023-01-27Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LACOSAMIDELACOSAMIDEXLCare Pharmaceuticals Inc.c7793da3-787b-4364-9192-7caab49066f12023-01-27Warnings, Adverse reactionsExact identifier
rxcui: 809974
unii: 563KS2PQY5
lacosamideLACOSAMIDEMSN LABORATORIES PRIVATE LIMITED0ae4e2d1-305d-4045-95da-cfe7c2d8b4352022-04-21Exact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEIndoco Remedies Limited145b4fae-ce6d-43e8-a474-fcb9dff92a532022-03-09Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5

Reported adverse events (FAERS/openFDA)#

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