Melphalan Hydrochloride

Product NDC
75907-112
11-digit product format
759070112
Labeler code
75907
Product ID
75907-112_853ed2e5-9423-6f18-b93f-31a29d1ed7e4
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
2024-06-26
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
75907-112-11Melphalan Hydrochloride1 in 1 CARTONKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-112-11EA - Each75907-112ea845768-aed0-482e-8657-b70c7a45afe912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-112MELPHALAN HYDROCHLORIDE KIT [DR.REDDY'S LABORATORIES INC]1Current NDC, 1 package rows20240706_bd5e4db5-8787-4428-2cb6-ef6f8a5e08af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSNbd5e4db5-8787-4428-2cb6-ef6f8a5e08af1
311487melphalan 50 MG InjectionSCDbd5e4db5-8787-4428-2cb6-ef6f8a5e08af1
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSYbd5e4db5-8787-4428-2cb6-ef6f8a5e08af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-112-11759070112111 KIT in 1 CARTON (75907-112-11) * 10 mL in 1 VIAL, SINGLE-DOSE (75907-111-11) * 10 mL in 1 VIAL, SINGLE-USE (75907-110-11) 1 kit2024-06-26NoNoCurrent