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 130 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltdf531053d-82e4-7613-e053-2995a90a349f2024-07-02WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd1ae5c268-1834-4ac2-931e-bb7fd0088cd22024-07-02WarningsExact identifier
unii: 3K9958V90M
B-Pure Hydrating Hand Sanitizer Cucumber Mint ScentedALCOHOLFourstar Group USA, Inc.0a228b06-0e1d-6c75-e063-6294a90a9a0e2024-07-02WarningsExact identifier
unii: 3K9958V90M
B-Pure Hydrating Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Inc.0a229252-6368-7d52-e063-6294a90a0bc72024-07-02WarningsExact identifier
unii: 3K9958V90M
MY MEDIC SUPER SANITIZERETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf32024-07-02WarningsExact identifier
unii: 3K9958V90M
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Ince7930ec4-6920-4abb-adce-8cc4de44801d2024-07-02WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLBiocosmetica Excel Argentinaaefcbf7b-3524-9e28-e053-2995a90a5a422024-06-30WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLExelencia Importers, Corp.abffec96-20e5-fd78-e053-2a95a90a4b082024-06-30WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.3fc74eff-46d6-45f5-bfa5-76a6a923cb942024-06-28WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Inc.102d3955-be15-4c1c-b097-c566d675ab7c2024-06-28WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Aloe ScentedALCOHOLFOURSTAR GROUP USA, INC.efd7a413-d29b-4b18-97bb-82746376e3df2024-06-25WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Eucalyptus ScentedALCOHOLFOURSTAR GROUP USA, INCd154ca37-a28d-48fb-94c8-add632c82bdc2024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Gel LeavesALCOHOLBath & Body Works, Inc.1ba7e3fe-d83c-db66-e063-6394a90a3b3a2024-06-25WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Shea Butter ScentedALCOHOLFOURSTAR GROUP USA, INC.1eca1353-3422-4e78-96a5-dd4603c04aac2024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Raspberries and Whipped VanillaALCOHOLBath & Body Works, Inc.1bbaa102-f43e-a7e8-e063-6394a90a89e82024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mahogany CoconutALCOHOLBath & Body Works, Inc.1bba9390-36ba-20e2-e063-6294a90a4b882024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Kitchen MandarinALCOHOLBath & Body Works, Inc.1bbaa157-5f45-1c6c-e063-6294a90a11152024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel White Tea and SageALCOHOLBath & Body Works, Inc.1bba9834-3c87-f5af-e063-6394a90aa6bd2024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Palo Santo and SageALCOHOLBath & Body Works, Inc.1ba4242c-4427-02e9-e063-6394a90a7c082024-06-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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