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 95 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care CARAMEL HONEY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.ffd8dfae-3205-455d-8bbe-9e9f8ee859e12025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET CITRUS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5bcc5f69-713c-45c5-aa19-6a1086c71c352025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care JUICY BERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.8f9feca1-59e9-4be9-9b89-0a615be159ef2025-06-16WarningsExact identifier
unii: 3K9958V90M
Smart Care PISTACHIO BRULE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.3a88b38c-f754-4756-be73-e1c03fe607302025-06-16WarningsExact identifier
unii: 3K9958V90M
Lacura Moisturizing Hand SanitizerETHYL ALCOHOL 62%Aldidafa52fe-42e6-2c21-e053-2995a90a413f2025-06-13WarningsExact identifier
unii: 3K9958V90M
RefresherALCOHOLJao Limited1debc8ca-2ea4-40c3-ad1e-8c1dc763d0f82025-06-13WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Sugar Plum ScentedALCOHOLFourstar Group USA, Inc.5a1a58d4-dddf-45f7-a327-b18a6eed44d42025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Cucumber Melon HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.cdae74d9-48a7-47dc-b006-8e2b0c2562572025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Citrus HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3c1581c6-c615-463e-83ad-cc84391b80e72025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.371ef8bb-9e3e-e5cc-e063-6394a90a4b6e2025-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer SpidermanALCOHOLShenzhen Lantern Scicence Co.,Ltd.371f6cbb-0164-e82d-e063-6294a90ae2df2025-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer --SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.371b5429-a392-02d0-e063-6294a90a7fe82025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer TransformerALCOHOLShenzhen Lantern Scicence Co.,Ltd.371c47f6-ba88-4a7c-e063-6294a90a16972025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Passion Fruit HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0fec6b2c-21ac-44ae-8e84-5e3795fdd5d52025-06-06WarningsExact identifier
unii: 3K9958V90M
Singular WipesALCOHOLSINGULAR ENTERPRISES LLC03957345-ccd0-4def-b528-7733e6a24cbb2025-06-06WarningsExact identifier
unii: 3K9958V90M
Singular Wipes lavender fragranceALCOHOLSINGULAR ENTERPRISES LLC9499fde0-ec1c-4880-b83b-62bc78686d992025-06-06WarningsExact identifier
unii: 3K9958V90M
Travel Wipes Moisturizer and fragranceALCOHOLSINGULAR ENTERPRISES LLC46024d13-84dd-47a9-af76-d2feba62448c2025-06-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer WipesALCOHOLSouthern Telecom, Inc.a6d06b25-735a-73c1-e053-2995a90a8b3c2025-06-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hibiscus HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.78fca09a-b4be-408b-b6e2-23df558e76702025-06-05WarningsExact identifier
unii: 3K9958V90M
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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