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 18 of 158 · 3,156 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt AirETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55726238-3b6b-55a2-e063-6394a90a570a2026-06-29WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple SplashETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.555d7248-8cc8-fe70-e063-6294a90a69a42026-06-28WarningsExact identifier
unii: 3K9958V90M
COCONUT ANTIBACTERIAL HAND SANITIZERALCOHOLENCHANTE ACCESSORIES INC.270dcb5d-113b-4278-b61e-a8808846c8952026-06-27WarningsExact identifier
unii: 3K9958V90M
ORANGE CITRUS ANTIBACTERIAL HAND SANITIZERALCOHOLENCHANTE ACCESSORIES INC.86b77b42-53a1-4f9f-a607-18b1ddc04c442026-06-27WarningsExact identifier
unii: 3K9958V90M
WILD CHERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e958f-414d-9917-e063-6294a90aa9772026-06-26WarningsExact identifier
unii: 3K9958V90M
VANILLA HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552ebc73-6e43-3527-e063-6394a90af58a2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pumpkin CarvingALCOHOLBath & Body Works, Inc.38e20b39-a453-7fb3-e063-6394a90aec9f2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Dazzling DiamondALCOHOLBath & Body Works, Inc.43543448-20b6-3fff-e063-6294a90a6da02026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Island MargaritaALCOHOLBath & Body Works, Inc.38e1d9e9-08e9-3908-e063-6294a90adf6b2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Blush PetalsALCOHOLBath & Body Works, Inc.552fa251-6e0e-ce9f-e063-6394a90a14e12026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Waikiki Beach CoconutALCOHOLBath & Body Works, Inc.552f9bc7-3158-a502-e063-6294a90a2d712026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Malibu MistALCOHOLBath & Body Works, Inc.552f9e7b-b278-ce3a-e063-6394a90ae9ab2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.552fa3e5-00b8-3825-e063-6294a90a1b0b2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Guava GlowALCOHOLBath & Body Works, Inc.552f9e7b-b275-ce3a-e063-6394a90ae9ab2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Strawberry BiteALCOHOLBath & Body Works, Inc.552f9cd1-3597-e2aa-e063-6294a90a82192026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray In The StarsALCOHOLBath & Body Works, Inc.552fa1b9-497c-cde8-e063-6394a90a89b52026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.552f95c9-e6e0-a1d7-e063-6294a90a83d62026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Fresh WatermelonALCOHOLBath & Body Works, Inc.552f9bc7-3159-a502-e063-6294a90a2d712026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Vanilla WhipALCOHOLBath & Body Works, Inc.552fa700-4214-d614-e063-6394a90aa12f2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Disney Princess BelleALCOHOLBath & Body Works, Inc.552fbc4a-1f6c-d72a-e063-6294a90aebb22026-06-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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