FDA.reportPublic FDA data

NDC 10139-319 - Melphalan Hydrochloride

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
10139-319
Package NDCs from labels
10139-319-10
Manufacturer
GeneraMedix Inc. | Coldstream Laboratories Inc
Effective date
2009-10-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Melphalan Hydrochloride - GeneraMedix Inc. | Coldstream Laboratories IncGeneraMedix Inc. | Coldstream Laboratories Inc2009-10-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10139-319-10Melphalan Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION10 mL50 mg in 10mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10139-319MELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2Unmatched20091120_e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELPHALAN HYDROCHLORIDEACTIVE INGREDIENT1VXP4V453TMELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2
MELPHALANACTIVE MOIETYQ41OR9510PMELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2