Melphalan hydrochloride

Product NDC
23155-355
11-digit product format
231550355
Labeler code
23155
Product ID
23155-355_64df9058-d4f2-4301-b5e4-19e3aed9747c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan hydrochloride
Dosage form
KIT
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA206523
Marketing category
ANDA
Marketing start
2025-03-28
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-355-41Melphalan hydrochloride1 in 1 CARTONKIT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-355-41EA - Each23155-35560361c00-bab3-4fde-a2d4-d38f2fb5083812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-355MELPHALAN HYDROCHLORIDE (MELPHALAN HYDROCHLORIDE) KIT [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]9Current NDC, 1 package rows20250330_2c18beeb-7bd4-4591-94cb-9d7156c1b8e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSN2c18beeb-7bd4-4591-94cb-9d7156c1b8e09
311487melphalan 50 MG InjectionSCD2c18beeb-7bd4-4591-94cb-9d7156c1b8e09
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSY2c18beeb-7bd4-4591-94cb-9d7156c1b8e09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-355-41231550355411 KIT in 1 CARTON (23155-355-41) * 10 mL in 1 VIAL (23155-353-31) * 10 mL in 1 VIAL (23155-354-31) 1 kit2025-03-28NoNoCurrent