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 115 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Snowflakes and CashmereALCOHOLBath & Body Works, Inc.29a654df-0169-830e-e063-6394a90a10622024-12-19WarningsExact identifier
unii: 3K9958V90M
eZFoam Foaming Alcohol Hand SanitizerFOAMING HAND SANITIZERKutol Products Company1f56b4c5-d703-4193-83a8-3be815c8acda2024-12-18WarningsExact identifier
unii: 3K9958V90M
Santi-Gel Instant Hand SanitizerSANTI-GEL INSTANT HAND SANITIZERKutol Products Company, Inc.f5bb2593-e036-4586-a807-2049e06b24752024-12-18WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
unii: 3K9958V90M
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
unii: 3K9958V90M
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
unii: 3K9958V90M
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLNatures Formulae Health Products Ltd.a7da75b3-b55d-641c-e053-2995a90a43b72024-12-17WarningsExact identifier
unii: 3K9958V90M
Foster and Thrive Decolorized IodineALCOHOL LIQUIDStrategic Sourcing Services, LLC2981529a-2bd0-3e9e-e063-6294a90a72362024-12-17WarningsExact identifier
unii: 3K9958V90M
PURELL VF PLUS Hand Sanitizer GelALCOHOLGOJO Industries, Inc.788a154e-f32f-410f-8648-f0bbd0772e662024-12-16WarningsExact identifier
unii: 3K9958V90M
SAN X E3ALCOHOLAmerisan, LLCd6e219a6-f4d6-b8df-e053-2995a90a58032024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Moisturizing 2in1 FoamALCOHOLGOJO Industries, Inc.19d4a358-74e0-4333-ace9-ed8b4ce729992024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.333246ca-9420-44c9-9240-37a9cdc03e2b2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Naturals FoamALCOHOLGOJO Industries, Inc.0b881323-938b-405f-beb2-0875256d37222024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer PRIME DEFENSEALCOHOLGOJO Industries, Inc.9962349e-ed78-4b22-be00-e38ab0c55dfe2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Lavender and VerbenaALCOHOLGOJO Industries, Inc.6a17d905-a55e-413c-b2af-0b06bf0d35c32024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP UnscentedALCOHOLGOJO Industries, Inc.f87058df-2efd-4ea8-ae37-35e472bd091f2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Tangerine and PearALCOHOLGOJO Industries, Inc.92df06a9-826b-493c-b865-295b8e9acb142024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Waterless Surgical ScrubALCOHOLGOJO Industries, Inc.e3ed5e0c-1e21-47eb-a999-9c8aa5083dff2024-12-16WarningsExact identifier
unii: 3K9958V90M
Soft Care Impact Alcohol Instant Hand SanitizerALCOHOLDiversey, Inc.938d5a47-f18f-4bae-bd65-4fc98985e4282024-12-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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