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 133 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Danbury ShortbreadALCOHOLBath & Body Works, Inc.1a8e81c0-c97d-100c-e063-6394a90ab2072024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Diamond Of The SeasonALCOHOLBath & Body Works, Inc.1a8e710e-521f-2d66-e063-6394a90a80de2024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Dressed In WhiteALCOHOLBath & Body Works, Inc.1a8eaa81-c110-69f1-e063-6394a90ab2642024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ebd8c-f7c6-9bf8-e063-6394a90ad8a82024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ee169-fec2-d98a-e063-6294a90a19792024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus RainALCOHOLBath & Body Works, Inc.1a8f680b-ab3f-a550-e063-6394a90ac9512024-06-10WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Salted Caramel ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38e171-e2fb-206c-e063-6294a90ac6382024-06-06WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Caramel Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38d19b-7c00-1c2b-e063-6394a90a4caa2024-06-06WarningsExact identifier
unii: 3K9958V90M
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Anti Bacterial Hand Gel Calypso ClementineALCOHOLBath & Body Works, Inc.1a25084f-b8d7-1188-e063-6294a90a1e962024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Candy Apple CauldronALCOHOLBath & Body Works, Inc.1a251228-7fda-5a38-e063-6294a90a5d082024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne Apple and HoneyALCOHOLBath & Body Works, Inc.1a252344-cf76-752e-e063-6294a90a010f2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Chasing DaydreamsALCOHOLBath & Body Works, Inc.1a25aac4-34f8-0371-e063-6294a90ac0822024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Coffee and WhiskeyALCOHOLBath & Body Works, Inc.1a25de73-8740-c98d-e063-6394a90afffb2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Crystal Blue CoastALCOHOLBath & Body Works, Inc.1a25f084-5228-b3ef-e063-6294a90a98822024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Brightest BloomALCOHOLBath & Body Works, Inc.1a128ecb-230f-0882-e063-6294a90a41372024-06-04WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Brown Sugar Toaster TreatALCOHOLBath & Body Works, Inc.1a12d9ca-fec4-2adc-e063-6394a90ab1812024-06-04WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel ButterflyALCOHOLBath & Body Works, Inc.1a12dbf3-2d95-291c-e063-6394a90a1efd2024-06-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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