Melphalan Hydrochloride

Product NDC
10139-321
11-digit product format
101390321
Labeler code
10139
Product ID
10139-321_e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan Hydrochloride
Dosage form
KIT
Labeler
GeneraMedix Inc.
Application
ANDA090299
Marketing category
ANDA
Marketing start
2009-10-27
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f87e8f-8550-4326-8f00-643b28e8aa5fProduct name820250617
d20f1fbb-d49e-414f-841c-a03ebbf763aaProduct name120241009
095b9d9e-47ea-8623-0363-760d047199b8Product name220170607
f096f23d-a1a3-49d0-b114-cd8666319a02Product name120160422

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10139-321-012019-10-21C16284748780-1956f9ecf-ca1a-621f-e053-dbdaa90a74ade77d77f3-3e96-4ff3-a42d-8bd67dfcf58b

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
10139-321-01Melphalan Hydrochloride1 in 1 CARTONKIT12

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10139-321MELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2Legacy NDC, 2 package rows20091120_e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSNe77d77f3-3e96-4ff3-a42d-8bd67dfcf58b2
311487melphalan 50 MG InjectionSCDe77d77f3-3e96-4ff3-a42d-8bd67dfcf58b2
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSYe77d77f3-3e96-4ff3-a42d-8bd67dfcf58b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10139-319-101013903191010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
10139-321-01101390321011 in 1 CARTONHistorical