Melphalan Hydrochloride

Product NDC
43598-392
11-digit product format
435980392
Labeler code
43598
Product ID
43598-392_7f4cc8ff-4b1c-86d8-ea19-0bab41202737
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan Hydrochloride
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA203655
Marketing category
ANDA
Marketing start
2017-12-18
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
43598-392-48Melphalan Hydrochloride1 in 1 CARTONKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-392-48EA - Each43598-392ba006307-b4bd-4ff3-8787-0a444081772812018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-392MELPHALAN HYDROCHLORIDE KIT [DR.REDDY'S LABORATORIES INC]8Current NDC, Legacy NDC, 1 package rows20210717_d4705154-3050-1a5c-950f-e24b51487401.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSNd4705154-3050-1a5c-950f-e24b514874018
311487melphalan 50 MG InjectionSCDd4705154-3050-1a5c-950f-e24b514874018
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSYd4705154-3050-1a5c-950f-e24b514874018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-392-48435980392481 KIT in 1 CARTON (43598-392-48) * 10 mL in 1 VIAL, SINGLE-DOSE (43598-391-50) * 10 mL in 1 VIAL, SINGLE-USE (43598-393-35) 1 kit2017-12-180000-00-00NoNoCurrent