Melphalan Hydrochloride

Product NDC
25021-258
11-digit product format
250210258
Labeler code
25021
Product ID
25021-258_6c52e5c7-4b97-451c-aacd-b43046fd164a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan Hydrochloride
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA209826
Marketing category
ANDA
Marketing start
2024-04-01
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
25021-258-61Melphalan Hydrochloride1 in 1 CARTONKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-258-61EA - Each25021-2584a46c812-4c4c-4460-ae3f-4480f834f60712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-258MELPHALAN HYDROCHLORIDE KIT [SAGENT PHARMACEUTICALS]1Current NDC, 1 package rows20240402_35f3d9fe-3c2f-4362-9d40-cdab014cac38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSN35f3d9fe-3c2f-4362-9d40-cdab014cac381
311487melphalan 50 MG InjectionSCD35f3d9fe-3c2f-4362-9d40-cdab014cac381
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSY35f3d9fe-3c2f-4362-9d40-cdab014cac381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-258-61250210258611 KIT in 1 CARTON (25021-258-61) * 10 mL in 1 VIAL (25021-256-10) * 10 mL in 1 VIAL (25021-257-10) 1 kit2024-04-01NoNoHistorical