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 16 of 221 · 4,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle Moisturizing Hand Sanitizer White Tea BlossomALCOHOLMy Imports USA LLC7ab834ef-a2f2-410a-92af-fb2cbcf845a32026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Aloe Cucumber MistALCOHOLMy Imports USA LLCabba3e7f-e79f-4c37-91dd-9e9aaf0a97f52026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sea Salt AirALCOHOLMy Imports USA LLCcbecb4d1-d00a-439f-9d10-910b47c216ca2026-07-15WarningsExact identifier
unii: 3K9958V90M
Spectrum Hand Sanitizer WipesETHYL ALCOHOLMedline Industries, LP8642a2b5-b34e-5bbd-e053-2991aa0a55a02026-07-15WarningsExact identifier
unii: 3K9958V90M
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LacosamideLACOSAMIDEGland Pharma Limited779d2381-f590-45f9-a191-f44af821f4c82026-07-14Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.568f791d-d6c3-7092-e063-6294a90a4b522026-07-14WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED SUGAR COOKIE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb528515a-ca0e-4184-b732-07fae3b380a52026-07-13WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f4a507-df3f-e265-e063-6294a90acd112026-07-13WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f81b63-2b08-77b1-e063-6294a90afeba2026-07-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited7171f607-90cc-4750-9928-20792ac2eaa22026-07-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited3417a685-544b-4dd0-b3e9-b5c463a679b62026-07-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited91d4c729-ebbe-45db-a4cd-dbf6bd542a292026-07-13WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC565650e6-e5f9-c010-e063-6394a90aacfa2026-07-11WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Blue DriftwoodALCOHOLScent Theory Products LLC56572ebe-d624-6389-e063-6394a90a23b42026-07-11WarningsExact identifier
unii: 3K9958V90M
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Purell Advanced SoothingALCOHOLGOJO Industries, LLC59b47629-8b4e-4084-8bc8-66c7e5599e9c2026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Gentle and Free FoamALCOHOLGOJO Industries, LLC70b13f86-4d1a-4221-b09d-7438163fe9b52026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Fragrance Free FoamALCOHOLGOJO Industries, LLC63c26f36-4bae-4cce-bacb-d0da66b228f72026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Fresh SqueezeALCOHOLAmerican Exchange Group6a668197-1fa8-4c07-a520-20e194df39c52026-07-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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