FDA.reportPublic FDA data

NDC 52609-3002 - 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
52609-3002
Package NDCs from labels
52609-3002-0
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 135 of 156 · 3,109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 6DC9Q167V3
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
Aire-Master Hand SanitizerALCOHOLWhisk Products, Inc.138fef3e-feb9-8788-e063-6394a90a4bad2024-03-13WarningsExact identifier
unii: 3K9958V90M
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Transcend Alco-Foam Hand SanitizerALCOHOLVon Drehle Corporation132b4d76-e08f-b359-e063-6394a90a95d42024-03-08WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLSafetec of America, Inc.0f6f2a67-4fed-407e-a2c5-51574a5bbf652024-03-01WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Hand Sanitizer Moisurize with Vitamin E and AloeETHYL ALCOHOLRejoice International2851ad2a-e108-424c-86d6-c898567695ef2024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Hand Sanitizer Moisturize with Vitamin EETHYL ALCOHOLRejoice International13c99570-0859-4310-843a-5eb266698eb32024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationala339dfd9-7cb8-4198-bc2a-9759648cf34e2024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationalf15a90e2-4a1e-452a-b9ac-5eb6f7b3dc722024-02-28WarningsExact identifier
unii: 3K9958V90M
Han-I-Size UnscentedALCOHOLMomar Incorporated12d843ae-8175-264d-e063-6294a90ac8c02024-02-23WarningsExact identifier
unii: 3K9958V90M
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd11ef87cc-6ff6-511b-e063-6294a90a662f2024-02-21WarningsExact identifier
unii: 3K9958V90M
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLMY IMPORTS USA LLC11f19126-6abb-b14c-e063-6294a90a4e342024-02-21WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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