FDA.reportPublic FDA data

NDC 52609-3003-0 - 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
Requested NDC
52609-3003-0
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 151 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jasmine scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c55e09b0-c61f-3037-e053-2995a90a72e22023-10-26WarningsExact identifier
unii: 3K9958V90M
CHERRY BLOSSOM SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.06e7d79d-6c12-45db-8da4-96f8505966bd2023-10-26WarningsExact identifier
unii: 3K9958V90M
BERRY SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.87887e2c-dde0-4753-8f7a-2747a1ff2a9d2023-10-26WarningsExact identifier
unii: 3K9958V90M
CHAI LATTE SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.4925eaed-f427-44dd-a456-d00aaec6a0322023-10-26WarningsExact identifier
unii: 3K9958V90M
CHAI LATTE SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.144d694a-b807-44fe-af13-91b8de1605812023-10-26WarningsExact identifier
unii: 3K9958V90M
PUMPKIN SPICE SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.f4de93d9-ac50-45af-aacd-62c7b325ce1c2023-10-26WarningsExact identifier
unii: 3K9958V90M
Aloe Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.d641ac0d-c25b-4727-b7da-107cdc3312af2023-10-26WarningsExact identifier
unii: 3K9958V90M
PUMPKIN SPICE SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.7b099ca8-3045-416d-86f0-36885a280b622023-10-26WarningsExact identifier
unii: 3K9958V90M
Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.f87f4df2-a595-45e7-b1d0-8f0247c270932023-10-26WarningsExact identifier
unii: 3K9958V90M
Jasmine Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.a1d07799-1b5d-464f-bfe3-3779706375d82023-10-26WarningsExact identifier
unii: 3K9958V90M
Rose Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.b986a0e8-aadf-44dd-a1a8-dcea7c1e66b52023-10-26WarningsExact identifier
unii: 3K9958V90M
Zeyco Antiseptic Hand Sanitizer GelALCOHOLLaboratorios Zeyco, S.A. de C.V.a85df538-dedd-7617-e053-2995a90a4a362023-10-26WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.ad14b387-e280-8dab-e053-2995a90a590c2023-10-26WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.a58cf759-0485-6740-e053-2a95a90a8b432023-10-26WarningsExact identifier
unii: 3K9958V90M
Zeyco Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa073f96-5774-c12f-e053-2a95a90aec222023-10-26WarningsExact identifier
unii: 3K9958V90M
Monarch Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa920f62-352c-4c67-9575-e78f12edef842023-10-26WarningsExact identifier
unii: 3K9958V90M
INSTANT FREE HAND SANITIZERALCOHOLTravel Retail Global Inca3ffa72b-b7d4-463a-a880-66081f16bd1a2023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Berry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.8a465ff2-5cb5-43bc-a9a7-d4e2162ac90d2023-10-25WarningsExact identifier
unii: 3K9958V90M
Justice 198824 You Rock Antibacterial Cotton Candy Blueberry Hand SanitizerALCOHOLTween Brands,Inc.84c4fb4b-9f63-4414-b8f3-39f65212f22a2023-10-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLBath Concept Cosmetics (Dongguan) Co., Ltd065e083f-3c13-495d-8619-df45c5fce68b2023-10-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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