FDA.reportPublic FDA data

NDC 52609-3003-0 - 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
Requested NDC
52609-3003-0
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 119 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.1c018851-82e0-4f2c-8f40-31674cd6fe2b2024-12-05WarningsExact identifier
unii: 3K9958V90M
ALPET E3 HAND SANITIZER FOAMALCOHOLBest Sanitizers, Inc.53573e1a-a3f8-4598-8248-ec4a62392d002024-12-05WarningsExact identifier
unii: 3K9958V90M
SMART SAN HAND SANITIZER FRAGRANCE-FREEALCOHOLBest Sanitizers, Inc.bce412dc-21db-4c63-b4fc-33538cda74242024-12-05WarningsExact identifier
unii: 3K9958V90M
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.8a2cc051-604c-43a7-9f65-2f929b759daa2024-12-05WarningsExact identifier
unii: 3K9958V90M
OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d05fbe85-26de-0d24-e053-2a95a90ab5cb2024-12-05WarningsExact identifier
unii: 3K9958V90M
BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d334b7f0-01dc-7f59-e053-2a95a90a06b52024-12-05WarningsExact identifier
unii: 3K9958V90M
alcohol pad 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.03a6e8d4-535d-b316-e063-6294a90aebf52024-12-04WarningsExact identifier
unii: 3K9958V90M
Watermelon Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f0f9885-2ad5-09de-e063-6394a90ad0d72024-12-03WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45afc52b-9838-1729-e054-00144ff8d46c2024-12-03WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Calming LavenderALCOHOLGOJO Industries, Inc.72244148-ad7e-47cf-96ff-48fc7f25d67d2024-12-03WarningsExact identifier
unii: 3K9958V90M
Sanitizing Hand Mist UnscentedETHYL ALCOHOLALO New York LLCe194daee-2197-4718-e053-2a95a90a48902024-12-03WarningsExact identifier
unii: 3K9958V90M
Instant Hand AntisepticALCOHOLASP Global291eaa18-81f8-6907-e054-00144ff88e882024-12-03WarningsExact identifier
unii: 3K9958V90M
Aquabain Instant Hand SanitizerETHYL ALCOHOL 70%Industria La Popular, S.A.b2e4d58d-adff-3cb2-e053-2995a90a392e2024-12-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vanilla NoirALCOHOLBath & Body Works, Inc.284ee56f-36e1-c5f9-e063-6294a90a62512024-12-02WarningsExact identifier
unii: 3K9958V90M
Servo Stat-FoamALCOHOLEnzyme Solutions, Inc.a4535b70-04cb-4227-81d3-4dd55086ba7a2024-11-26WarningsExact identifier
unii: 3K9958V90M
Servo-StatALCOHOLEnzyme Solutions, Inc.70562cae-b316-4033-b457-40ba71f6881c2024-11-26WarningsExact identifier
unii: 3K9958V90M
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
First Aid Only Instant Hand SanitizerALCOHOLAcme United Corporationc94e8db3-2db7-fce4-e053-2a95a90a62d92024-11-26WarningsExact identifier
unii: 3K9958V90M
Fresh Nap Plus Hand SanitizerETHYL ALCOHOLAcme United Corporationfdc8aca2-aec5-0832-e053-6394a90a61402024-11-26WarningsExact identifier
unii: 3K9958V90M
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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