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 109 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KeriCure Hand SanitizerALCOHOLKericure Inc.de516d2e-9c16-4bd2-b4c2-7e2f9fd264422025-01-22WarningsExact identifier
unii: 3K9958V90M
KeriCure Hand SanitizerALCOHOLKericure Inc.caa98aaa-1307-41df-a59d-258e1edd30812025-01-22WarningsExact identifier
unii: 3K9958V90M
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
unii: 3K9958V90M
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
unii: 3K9958V90M
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
unii: 3K9958V90M
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Smart Care Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1b125c5d-7041-c71b-e063-6394a90add9b2025-01-17WarningsExact identifier
unii: 3K9958V90M
Berry Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f128054-4c57-8055-e063-6294a90adc4e2025-01-17WarningsExact identifier
unii: 3K9958V90M
SANI-CLAWSANI-CLAWHomeland Industrial Supply2be875a1-0e9d-2e2a-e063-6394a90a15202025-01-17WarningsExact identifier
unii: 3K9958V90M
ROAME Moisturizing Hand Sanitizer Cloud 999ALCOHOL HAND SANITIZERRoame LLC2bb1003e-8e4c-8dd8-e063-6294a90ad37d2025-01-14WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
unii: 3K9958V90M
SaniiSwabETHYL ALCOHOLPOLLEY MED LLC2ad08239-18ea-9ec9-e063-6394a90a3a542025-01-10WarningsExact identifier
unii: 3K9958V90M
AntibacterialALCOHOLHenry Schein Inc.87446203-1365-49b6-9346-62fb8ec783112025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.e80feb63-2c51-4164-806d-778e39e620e82025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.3b075cdc-509d-4259-99a2-0e219998949d2025-01-10WarningsExact identifier
unii: 3K9958V90M
Hand Guard Foaming Alcohol Instant Hand SanitizerALCOHOLWechem, Inc.2b60cd24-f0a9-5c54-e063-6394a90ab3502025-01-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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