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
Label	Manufacturer	Effective date	Type
ALKERAN ® (melphalan hydrochloride) for Injection	ApoPharma USA, Inc.	2022-12-05	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MELPHALAN HYDROCHLORIDE	ACTIVE INGREDIENT	1VXP4V453T	ALKERAN (MELPHALAN HYDROCHLORIDE) KIT [APO-PHARMA USA, INC]	6
MELPHALAN	ACTIVE MOIETY	Q41OR9510P	ALKERAN (MELPHALAN HYDROCHLORIDE) KIT [APO-PHARMA USA, INC]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALKERAN (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 157 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CVS Hand Sanitizer	ALCOHOL	CVS	d0081c50-c0d2-436a-ba83-5d1982ae64b7	2015-08-17	Warnings	Exact identifier unii: 3K9958V90M
Instant Hand Sanitizer	ALCOHOL	Safetec of America, Inc.	f9e30645-491b-4f54-acfd-f863ee235607	2013-08-07	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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