FDA.reportPublic FDA data

NDC 52609-3003 - ALKERAN

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
52609-3003
Package NDCs from labels
52609-3003-0
Manufacturer
ApoPharma USA, Inc.
Effective date
2022-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALKERAN ® (melphalan hydrochloride) for InjectionApoPharma USA, Inc.2022-12-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELPHALAN HYDROCHLORIDEACTIVE INGREDIENT1VXP4V453TALKERAN (MELPHALAN HYDROCHLORIDE) KIT [APO-PHARMA USA, INC]6
MELPHALANACTIVE MOIETYQ41OR9510PALKERAN (MELPHALAN HYDROCHLORIDE) KIT [APO-PHARMA USA, INC]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EALKERAN (MELPHALAN HYDROCHLORIDE) KIT [APO-PHARMA USA, INC]6

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 145 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand SanitizerALCOHOLProstock LLCa185c9c8-aabe-0e63-e053-2995a90a1b1e2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCce2d6c41-9423-45bd-8cbf-6749fdbb2c9f2023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLProstock LLC9e7d7912-d594-47e9-bd8a-cc4f8ac85b2c2023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLDegasa, S.A. de C.V.c93048f4-8c26-44c0-a966-7ef8662a7b312023-11-05WarningsExact identifier
unii: 3K9958V90M
Protec Hand Sani Gel AntibacterialALCOHOLDegasa, S.A. de C.V.78f0fcd0-96eb-4432-8e2a-da4c6d70cf9a2023-11-05WarningsExact identifier
unii: 3K9958V90M
Degasa Hand Sanitizer Lemon Lime ScentALCOHOLDegasa, S.A. de C.V.004bfacb-f79a-4f8a-9c8d-1d6e0dde1ce52023-11-05WarningsExact identifier
unii: 3K9958V90M
Iso-Quin hand sanitizerALCOHOLThe Hygenic Company, LLC.d1003c9f-a6f8-3de2-e053-2995a90a6e8a2023-11-05WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLDegasa, S.A. de C.V.6ccffef3-99c6-4663-b9d7-9f50216eb13f2023-11-05WarningsExact identifier
unii: 3K9958V90M
AMBI Soothing Hand sanitizerALCOHOLAMBI Enterprises, llc229a2afd-9f33-42b9-916d-df1e787181f72023-11-05WarningsExact identifier
unii: 3K9958V90M
Justice Cucumber And Melon Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.7823d0de-880e-4c56-acc7-b5c03dbf0e7a2023-11-03WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerINSTANT HAND SANITIZERClark Core Services, LLCbd452261-48f5-56b7-e053-2995a90a6dcf2023-11-02WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTravel Retail Global Inc.62ec5bf1-9467-4c9b-b83d-6709f2146e0a2023-10-31WarningsExact identifier
unii: 3K9958V90M
CleanGenic Foaming Hand SanitizerALCOHOLCleanGenic, LLCb9829141-8222-3381-e053-2995a90ac0332023-10-28WarningsExact identifier
unii: 3K9958V90M
CleanGenic 1 GALLON HAND SANITIZERALCOHOLCleanGenic, LLCb982987b-c462-1ade-e053-2995a90ae6f72023-10-28WarningsExact identifier
unii: 3K9958V90M
Foaming Alcohol Hand SanitizerALCOHOLSimoniz USA, Incd8925e9b-dd6e-4fad-aa3f-ae8fb895f2e12023-10-28WarningsExact identifier
unii: 3K9958V90M
CleanGenic 8 OZ HAND SANITIZERALCOHOLCleanGenic, LLCb9828dd7-63a1-0bf4-e053-2a95a90a45692023-10-28WarningsExact identifier
unii: 3K9958V90M
Simple Hygiene foaming hand Sanitizer 62ALCOHOLFULLER INDUSTRIES, INC64ceef51-78a6-4beb-a0aa-d4d5f9a0d84e2023-10-28WarningsExact identifier
unii: 3K9958V90M
Simple Hygiene Hand SanitizerALCOHOLFULLER INDUSTRIES, INCf2a4bdd0-f78b-4a62-b2d3-bb78e57886002023-10-28WarningsExact identifier
unii: 3K9958V90M
CleanGenic Foaming Hand SanitizerALCOHOLCleanGenic, LLCb982b2ed-6565-326a-e053-2a95a90a72d22023-10-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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