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 144 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCTORS TOUCH Hand SanitizerALCOHOLDOCTOR'S CHOICE MEDICAL, LLCfc169526-75c4-4451-8f2b-ef04dda3e3d62023-11-11WarningsExact identifier
unii: 3K9958V90M
LEMONBELLA Lavender Hand SanitizerALCOHOLLemonbella LLC98450cde-bfc9-4868-be45-6459e1c5e11f2023-11-11WarningsExact identifier
unii: 3K9958V90M
GeriGentle Hand WipesALCOHOLGeri-Gentle Corporation278b23f5-c3bd-48ae-8c8d-d537d521e0a42023-11-10WarningsExact identifier
unii: 3K9958V90M
TenderSant Hand SanitizerALCOHOLGeri-Gentle Corporation35966b11-756d-4156-8f5a-9bec1a5e11bb2023-11-10WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLDegasa, S.A. de C.V.cb2da26b-7ffe-485b-afc9-96fa9e5b80c72023-11-09WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLBeauty Partners LLC44e56110-da9b-4dde-b264-09a9f09a394b2023-11-08WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.51cc4062-a4ef-4504-91a8-4901c4a187802023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c56a823-bf7a-3005-e053-2a95a90a22e32023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.c7e94ccb-5ec4-4e35-b8d3-8e1f066f4bb82023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.27dd30e7-3e2c-4409-9cf1-66db27611c1b2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c574647-161d-6459-e053-2995a90a44702023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.075de65e-448f-40e8-b129-7647f923b7832023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c56afa2-c06c-fa03-e053-2995a90a74372023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c563e53-2246-cd57-e053-2995a90a82d72023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c5753a4-f8af-9f09-e053-2995a90ad1382023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.a29c47b9-1a99-5272-e053-2a95a90af4f62023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.50ac080f-ae60-49dd-a01f-7b9bd8ea73a82023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCa185a4b0-a5d3-2487-e053-2995a90a01d32023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERLS PROMOTIONS INC.3f8cae4e-a017-4db6-9a29-ebae65bba34c2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLC1f4833c5-fcac-4c01-a5c6-e72837ca0a482023-11-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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