FDA.reportPublic FDA data

NDC 0121-1012-05 - 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
0121-1012
Requested NDC
0121-1012-05
Package NDCs from labels
0121-1012-05, 0121-1012-95
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2024-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lacosamide - PAI Holdings, LLC dba PAI PharmaPAI Holdings, LLC dba PAI Pharma2024-05-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1012-05Lacosamide5 mL in 1 CUP, UNIT-DOSESOLUTION522
0121-1012-95Lacosamide10 in 1 TRAYSOLUTION1022
0121-1012-95Lacosamide1 in 1 CASESOLUTION122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1012LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]22Current NDC, 3 package rows20240601_75de00d8-d2e7-4025-be4e-f49299068e7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1012-05ML - Milliliter0121-10120550a7aa-39ed-4350-931e-796e0654784412023-05-05
0121-1012-95ML - Milliliter0121-1012e341afa4-3085-4835-9602-45d19dedf4b312023-05-05

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 20 of 221 · 4,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple SplashETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55982f73-7baa-26a7-e063-6394a90ab74b2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry CrumbleETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55981d2a-d4de-af08-e063-6294a90a4b7c2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti CupcakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ff1f-b134-0beb-e063-6394a90a39a12026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread CakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5598d6ca-39f6-ca2a-e063-6394a90abc0e2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha MistETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559832ca-df92-0c2d-e063-6294a90ab66f2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5599605b-28f0-a534-e063-6394a90a72132026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin CreamETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559987c0-7abd-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY STRAWBERRE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5740a2ed-e77d-3f41-e063-6394a90aec032026-07-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY VANILLA HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574ba9b9-b44d-b014-e063-6394a90af7682026-07-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY COTTON CANDY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bcf4f-ad36-5ede-e063-6294a90a0eab2026-07-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY COCONUT HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd57539bdd-641d-3c27-e063-6394a90af84a2026-07-01WarningsExact identifier
unii: 3K9958V90M
Laura Lynn Moisturizing Advanced Gel Hand SanitizerALCOHOLIngles Markets, Inc.57ebcdd5-09fd-74ce-e063-6294a90af0a12026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared PlumETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5572d336-f953-90ac-e063-6394a90a2d4d2026-06-30WarningsExact identifier
unii: 3K9958V90M
Gel Hand SanitizerALCOHOLIntercon Chemical Company5579be7d-1674-5602-e063-6394a90a81692026-06-30WarningsExact identifier
unii: 3K9958V90M
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry CrumbleETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.555da50d-f106-f27f-e063-6294a90a61f92026-06-29WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach SandalwoodETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55601f99-b1a7-ffb5-e063-6394a90a37d62026-06-29WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti CupcakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556073a0-242b-dc26-e063-6394a90a9ccf2026-06-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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