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 125 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand ReliefLOTIONDerma Glovee2f89d56-5624-4a94-8151-1edb508232ac2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand ReliefLOTIONDerma Gloved3926f48-3a42-42df-a850-47b3914ba3b62024-10-09WarningsExact identifier
unii: 3K9958V90M
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Glovebcd71f37-63aa-4ad9-a9be-e5519c7e66e72024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
unii: 3K9958V90M
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Gloveb4ff67d6-27d6-4d31-a708-9c2e8d4f0f3e2024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Glove1c46e4da-7594-48b0-8e8d-8031891184202024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc07a891a3-dcf7-438f-bbf7-a20b2aa7d7d72024-10-09WarningsExact identifier
unii: 3K9958V90M
MistALCOHOLDerma Glovedd849fb3-95af-4a32-9687-3b966d456fbb2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc0933de73-94b1-448e-b39f-ecffabf952882024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Gloved8705086-7209-4f13-bd54-604c90495f0a2024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Gloved158394e-baec-4770-8ee8-19285722ca612024-10-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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