Melphalan Hydrochloride

Product NDC
67184-0618
11-digit product format
671840618
Labeler code
67184
Product ID
67184-0618_442e0308-4efa-428d-9250-177b95fd4fee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
melphalan hydrochloride
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
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
67184-0618-2Melphalan Hydrochloride1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0618MELPHALAN HYDROCHLORIDE KIT [QILU PHARMACEUTICAL CO., LTD.]1Current NDC, 1 package rows20240705_91948ff9-6070-485b-b4b7-3cb477c1b24c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSN91948ff9-6070-485b-b4b7-3cb477c1b24c1
311487melphalan 50 MG InjectionSCD91948ff9-6070-485b-b4b7-3cb477c1b24c1
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSY91948ff9-6070-485b-b4b7-3cb477c1b24c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67184-0618-2671840618021 KIT in 1 CARTON (67184-0618-2) * 15 mL in 1 VIAL, SINGLE-DOSE (67184-0616-1) * 10 mL in 1 VIAL, SINGLE-USE (67184-0617-1) 1 kit2023-12-18NoNoCurrent