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 78 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
unii: 3K9958V90M
Symmetry Hand SanitizerALCOHOLBuckeye International, Inc.7f38c146-b5d3-489e-b1c7-89dcea2c18a82025-10-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Smart Care TEA and TIMBER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.f386dd34-325b-4c50-baf5-6b19c7953a752025-10-28WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLCharlotte Products Ltd.1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa2025-10-28WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZING LAVENDERALCOHOLDR. BRONNER'S MAGIC SOAPS8383605a-0bac-428c-b1cb-2f95ce9bd35e2025-10-28WarningsExact identifier
unii: 3K9958V90M
ORGANIC HAND SANITIZER PEPPERMINTALCOHOLDR. BRONNER'S MAGIC SOAPScad3a81e-88cb-4f44-a351-b086fd9837952025-10-28WarningsExact identifier
unii: 3K9958V90M
Smart Care CASHMERE CHAR HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5fbdf5ce-77e1-498e-9543-312d10f3705e2025-10-28WarningsExact identifier
unii: 3K9958V90M
Smart Care ZEN and ZEST HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e3637e26-78f7-4913-ba02-390365b93a6d2025-10-28WarningsExact identifier
unii: 3K9958V90M
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421cfe98-7a20-c37c-e063-6294a90ad4b52025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce33e-4639-e881-e063-6394a90a57ef2025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d994c-bf62-2f40-e063-6294a90a64882025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d2fd-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7bd9-c892-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d300-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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