Melphalan

Product NDC
54288-106
11-digit product format
542880106
Labeler code
54288
Product ID
54288-106_ed1da9d7-5192-44de-86b8-ebd3bece36b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan Hydrochloride
Dosage form
KIT
Labeler
BPI Labs LLC
Application
ANDA209197
Marketing category
ANDA
Marketing start
2020-09-30
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
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
54288-106-032022-01-30C16284748780-1d6a99b39-81d9-a426-e053-dadaa90af4c2Melphalan Hydrochloride for Injection
54288-106-032022-01-28C16284748780-1d6a99b39-81d9-a426-e053-dadaa90af4c2Melphalan Hydrochloride for Injection

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-106MELPHALAN HYDROCHLORIDE KIT [BPI LABS LLC]8Legacy NDC20250213_dab93975-0587-4f12-848c-9130bb02d036.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSNdab93975-0587-4f12-848c-9130bb02d0369
311487melphalan 50 MG InjectionSCDdab93975-0587-4f12-848c-9130bb02d0369
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSYdab93975-0587-4f12-848c-9130bb02d0369

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-106-03542880106031 KIT in 1 CARTON (54288-106-03) * 50 mg in 1 VIAL, GLASS (54288-108-01) * 10 mL in 1 VIAL, GLASS (54288-107-02) 1 kit2020-09-300000-00-00NoNoCurrent