Melphalan Hydrochloride

Product NDC
83634-202
11-digit product format
836340202
Labeler code
83634
Product ID
83634-202_47da36c6-67e2-44c7-93d8-4f236abb73e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
melphalan hydrochloride
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA211463
Marketing category
ANDA
Marketing start
2023-12-18
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
83634-202-61Melphalan Hydrochloride1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-202MELPHALAN HYDROCHLORIDE KIT [AVENACY INC.]1Current NDC, 1 package rows20231218_8edd78a9-d762-4578-a610-28d6595f4bf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSN8edd78a9-d762-4578-a610-28d6595f4bf31
311487melphalan 50 MG InjectionSCD8edd78a9-d762-4578-a610-28d6595f4bf31
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSY8edd78a9-d762-4578-a610-28d6595f4bf31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-202-61836340202611 KIT in 1 CARTON (83634-202-61) * 15 mL in 1 VIAL, SINGLE-DOSE (83634-200-15) * 10 mL in 1 VIAL, SINGLE-USE (83634-201-10) 1 kit2023-12-18NoNoCurrent