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 110 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemStation E3 Hand SanitizerETHANOLChemstation4a37ef06-b74b-1ed1-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: 3K9958V90M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: 1Q73Q2JULR
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr Tichenors First Aid AntisepticALCOHOLDr. G. H. Tichenor's Antiseptic Company9947855d-b8e0-4c22-a627-16b526242e392025-01-09WarningsExact identifier
unii: 3K9958V90M
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTempo Industries, Inc.af9a0d53-0d4a-6dc7-e053-2a95a90acc1c2025-01-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTempo Industries, Inc.af9a678b-488a-7045-e053-2995a90a401c2025-01-08WarningsExact identifier
unii: 3K9958V90M
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
unii: 3K9958V90M
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
unii: 3K9958V90M
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PentaCleanse Alcohol WipesALCOHOLPrestige Care Pharmacy Ince41a3e03-af01-5280-e053-2a95a90a8afc2025-01-08WarningsExact identifier
unii: 3K9958V90M
Gel Antiseptico DermowipeGEL ANTISEPTICO A BASE DE ALCOHOL ETILICOKey Qumica S.A. de C.V.15620afc-d6ae-0f34-e063-6294a90a8ad22025-01-07WarningsExact identifier
unii: 3K9958V90M
Sipa hand sanitizer with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbad83b-b8aa-a780-e053-6294a90a58ab2025-01-07WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Gingerbread BakeryALCOHOLBath & Body Works, Inc.2b0f53e3-eb4c-a372-e063-6394a90ae5df2025-01-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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