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 61 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EcoChoice Sterno Hand Sanitizer Lemon ZestALCOHOLSTERNO PRODUCTS, LLC576b7579-f44d-4315-a9c6-09d9a6d3f61d2026-01-07WarningsExact identifier
unii: 3K9958V90M
EcoChoice Sterno Hand Sanitizer Clean and FreshALCOHOLSTERNO PRODUCTS, LLC6647babe-1d1a-4a23-9042-66d950355c812026-01-07WarningsExact identifier
unii: 3K9958V90M
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD1a451616-b16e-8aa7-e063-6294a90a26a12026-01-07WarningsExact identifier
unii: 3K9958V90M
SPA HAND SANITIZER VANILLAETHYL ALCOHOLRejoice International Corp.47c3c187-da54-7c3b-e063-6294a90af3ce2026-01-06WarningsExact identifier
unii: 3K9958V90M
SPA HAND SANITIZER CHAMPAGNE BLASHETHYL ALCOHOLRejoice International Corp.47c5e9af-4ea8-fb39-e063-6394a90aa5ab2026-01-06WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLBPI Labs, LLC314b1dab-8f4f-49ae-a105-f974842818b82026-01-05Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand Sanitizing WipesHAND SANITIZING WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD37487da6-4e0e-6625-e063-6394a90a0af12026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Vanilla HeavenALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a0781b-9b25-f04b-e063-6294a90ae7e52026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a16397-dff3-7d79-e063-6394a90a040f2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.74176b95-7899-47c7-a330-87f603aa12f52026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Cucumber Mint ScentedALCOHOLFOURSTAR GROUP USA, INC.437cb27e-4a42-4f36-ae0a-9e456055a1832026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom ScentedALCOHOLFourstar Group USA, Inc.4e256c4a-6b58-4011-80f5-51d7527943de2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Sandstone Mist ScentedALCOHOLFourstar Group USA, Inc.a9809d18-48c9-483b-bba4-5e9257533d1f2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Pistachio Grove ScentedALCOHOLFourstar Group USA, Inc.8f6ac5e0-822a-4279-be62-e7fc3da161cd2026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Lemon LimeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeaae9-740d-a28a-e063-6294a90a64602026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeeef9-0eed-e7d0-e063-6394a90a6d312026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af27a7-3df9-270a-e063-6394a90abc7d2026-01-05WarningsExact identifier
unii: 3K9958V90M
Hand SanitiserALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a44d82bf-68a3-56bc-e053-2995a90ae5262026-01-05WarningsExact identifier
unii: 3K9958V90M
Green Island SanitiserALCOHOLZhejiang Guoyao Aerosol Co., Ltda7d1df16-3566-badf-e053-2a95a90aa61a2026-01-05WarningsExact identifier
unii: 3K9958V90M
Green IslandETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a7443a72-6ee5-07f7-e053-2995a90a33412026-01-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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