Melphalan Hydrochloride

Product NDC
84679-001
11-digit product format
846790001
Labeler code
84679
Product ID
84679-001_47e47c3a-eecb-263c-e063-6394a90a8864
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
melphalan hydrochloride
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Arthur Group LLC
Application
ANDA211463
Marketing category
ANDA
Marketing start
2024-11-30
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Melphalan Hydrochloride
Listing expiration
2027-12-31

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
84679-001-01Melphalan Hydrochloride1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84679-001MELPHALAN HYDROCHLORIDE KIT [ARTHUR GROUP LLC]1Current NDC, 1 package rows20241130_2254450e-4803-b947-e063-6394a90a4624.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSN2254450e-4803-b947-e063-6394a90a46242
311487melphalan 50 MG InjectionSCD2254450e-4803-b947-e063-6394a90a46242
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSY2254450e-4803-b947-e063-6394a90a46242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84679-001-01846790001011 KIT in 1 CARTON (84679-001-01) * 15 mL in 1 VIAL, SINGLE-DOSE (84679-002-01) * 10 mL in 1 VIAL, SINGLE-USE (84679-003-01) 1 kit2024-11-30NoNoCurrent