Melphalan

Product NDC
63323-760
11-digit product format
633230760
Labeler code
63323
Product ID
63323-760_f3373f9b-1680-411c-922f-df58a559a6aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan Hydrochloride
Dosage form
KIT
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203393
Marketing category
ANDA
Marketing start
2017-12-22
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Melphalan
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
63323-760-20Melphalan1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-760-20EA - Each63323-760b457e347-7950-4b6f-8a1b-a2a650e2e30a12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-760MELPHALAN (MELPHALAN HYDROCHLORIDE) KIT [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 1 package rows20250510_e9c2efee-173d-4795-96d8-7aae5b3a3073.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSNe9c2efee-173d-4795-96d8-7aae5b3a30736
311487melphalan 50 MG InjectionSCDe9c2efee-173d-4795-96d8-7aae5b3a30736
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSYe9c2efee-173d-4795-96d8-7aae5b3a30736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-760-20633230760201 KIT in 1 CARTON (63323-760-20) * 10 mL in 1 VIAL, SINGLE-DOSE (63323-761-20) * 10 mL in 1 VIAL, SINGLE-USE (63323-732-10) 1 kit2017-12-220000-00-00NoNoCurrent