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 11 of 158 · 3,156 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Pouch-Sweet PeaALCOHOLShenzhen Lantern Scicence Co.,Ltd.57a4be75-f0af-56c5-e063-6294a90aafc92026-07-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Green Certified GelALCOHOLGOJO Industries, LLC575d559d-c60a-7704-e063-6394a90a9c6b2026-07-24WarningsExact identifier
unii: 3K9958V90M
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
MISTIFY WATERMELON HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bf021-6352-e3fc-e063-6394a90ad6de2026-07-23WarningsExact identifier
unii: 3K9958V90M
Smart Care SUGAR COOKIE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.b7aac379-90d6-4039-9304-891056b40bc02026-07-22WarningsExact identifier
unii: 3K9958V90M
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Smart Care GINGERBREAD HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.cc22ca2f-9b1d-42b6-a3e4-29081f07a5be2026-07-22WarningsExact identifier
unii: 3K9958V90M
Midnight Magic Hand SanitizerALCOHOLScent Theory Products LLC5721d186-ec6d-fa26-e063-6294a90a76d22026-07-21WarningsExact identifier
unii: 3K9958V90M
Twisted Caramel Apple Hand SanitizerALCOHOLScent Theory Products LLC572a82e3-93ec-9af4-e063-6294a90a9c262026-07-21WarningsExact identifier
unii: 3K9958V90M
Molten Marshmallow Hand SanitizerALCOHOLScent Theory Products LLC572aa67e-52f7-b424-e063-6394a90ac4ae2026-07-21WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Smart Care SPICED CRANBERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e4dc41be-9b5b-4fcf-b7e7-8c6de3fcd5872026-07-21WarningsExact identifier
unii: 3K9958V90M
Andiamo Lake Como Hydra-Mist Refillable Hand SanitizerALCOHOLAndiamo LLCd0681ebe-2fed-43c4-9b4f-7ac0921aa2222026-07-20WarningsExact identifier
unii: 3K9958V90M
Andiamo Capri Hydra-Mist Refillable Hand SanitizerALCOHOLAndiamo LLC22ea5c3e-3bbf-44ec-8b74-b40742ae783a2026-07-20WarningsExact identifier
unii: 3K9958V90M
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.56a3ad5f-c34a-6b90-e063-6394a90a06e92026-07-19WarningsExact identifier
unii: 3K9958V90M
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56ca8257-6537-fb4e-e063-6294a90a49162026-07-17WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand Sanitizer Spray.ETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56caf683-bdf1-95e6-e063-6294a90a14d02026-07-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cbbfcf-3239-7c76-e063-6394a90a75b02026-07-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cd0c67-20dd-6783-e063-6294a90ae9102026-07-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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