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 92 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer MistETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.3abd4d79-3dd0-682a-e063-6294a90a28ef2025-07-25WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aab23c1-53ad-9e60-e063-6394a90a26ec2025-07-24WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aabb047-7277-d9cb-e063-6394a90a92242025-07-24WarningsExact identifier
unii: 3K9958V90M
Smart Care COCONUT BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.7088fa66-a972-4439-aef3-633808b5eafb2025-07-22WarningsExact identifier
unii: 3K9958V90M
BiopureHAND SANITIZER SPRAYQuest USA Corp3249f563-7968-e512-e063-6394a90aad522025-07-18WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1c90df-19ee-b249-e063-6394a90af33b2025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1cd4ae-4a6e-bfcc-e063-6394a90aad032025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1d0f0b-e330-f674-e063-6394a90aec492025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLMY IMPORTS USA LLC3a2a1165-b710-3bf6-e063-6294a90a352d2025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLMY IMPORTS USA LLC3a2a36bb-c55d-67a0-e063-6294a90a1cf42025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLMY IMPORTS USA LLC3a2a4539-30eb-7451-e063-6294a90a2c222025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLMY IMPORTS USA LLC3a2a4fab-6776-7359-e063-6294a90a85242025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a186822-025c-6970-e063-6394a90a5dc12025-07-16WarningsExact identifier
unii: 3K9958V90M
Smart Care WILD ROSE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e98e8f32-94f9-45b6-94b3-93c62a8a3f172025-07-16WarningsExact identifier
unii: 3K9958V90M
Smart Care CALMING LAVENDER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.38a7d367-7a33-48dc-84e7-fce894bf79fa2025-07-16WarningsExact identifier
unii: 3K9958V90M
Smart Care FRESH RAIN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.dfdd5255-9033-4a22-a03c-922c3a33d24d2025-07-15WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS Lovely Lavender Scent HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.73695c5e-664c-466f-9d84-ae4b115da23f2025-07-15WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholDEHYDRATED ALCOHOLIngenus Pharmaceuticals, LLC1d5ec6f9-d58f-4651-a4a1-93fec13fd4382025-07-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a417a8-afec-f893-e063-6394a90a70ae2025-07-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a4aecf-1e74-4589-e063-6394a90a34fb2025-07-11WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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