Melphalan Hydrochloride

Product NDC
67457-195
11-digit product format
674570195
Labeler code
67457
Product ID
67457-195_14d237c9-0b9f-4101-ae53-c6ffe9928801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan Hydrochloride
Dosage form
KIT
Labeler
Mylan Institutional LLC
Application
ANDA090270
Marketing category
ANDA
Marketing start
2013-01-10
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Melphalan Hydrochloride
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui311487

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-195-01Melphalan Hydrochloride1 in 1 CARTONKIT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-195-01EA - Each67457-19542ba57f8-365e-4f8a-bf8d-f77926680a1512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Melphalan HydrochlorideACTIVE INGREDIENT1VXP4V453TMELPHALAN HYDROCHLORIDE KIT [MYLAN INSTITUTIONAL LLC]6
MelphalanACTIVE MOIETYQ41OR9510PMELPHALAN HYDROCHLORIDE KIT [MYLAN INSTITUTIONAL LLC]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EMELPHALAN HYDROCHLORIDE KIT [MYLAN INSTITUTIONAL LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-195MELPHALAN HYDROCHLORIDE KIT [MYLAN INSTITUTIONAL LLC]10Current NDC, Legacy NDC, 1 package rows20201031_a8bf1877-fd06-4ef6-b82d-fe0ff1956bde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSNa8bf1877-fd06-4ef6-b82d-fe0ff1956bde10
311487melphalan 50 MG InjectionSCDa8bf1877-fd06-4ef6-b82d-fe0ff1956bde10
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSYa8bf1877-fd06-4ef6-b82d-fe0ff1956bde10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-195-01674570195011 KIT in 1 CARTON (67457-195-01) * 10 mL in 1 VIAL, GLASS (67457-193-50) * 10 mL in 1 VIAL, GLASS (67457-194-10) 1 kit2013-01-100000-00-00NoNoCurrent