Melphalan hydrochloride

Product NDC
71288-132
11-digit product format
712880132
Labeler code
71288
Product ID
71288-132_a02b7696-e6b3-46c9-9a66-142465157e70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan hydrochloride
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212960
Marketing category
ANDA
Marketing start
2021-05-28
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-132-90Melphalan hydrochloride1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-132-90EA - Each71288-132e5284ec4-9b3b-4408-aec0-b721f950093d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-132MELPHALAN HYDROCHLORIDE KIT [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20210610_d99b3865-e0f0-482a-9ec6-da642e5104ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311487melphalan 50 MG InjectionPSNd99b3865-e0f0-482a-9ec6-da642e5104ea3
311487melphalan 50 MG InjectionSCDd99b3865-e0f0-482a-9ec6-da642e5104ea3
311487melphalan (as melphalan hydrochloride) 50 MG InjectionSYd99b3865-e0f0-482a-9ec6-da642e5104ea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-132-90712880132901 KIT in 1 CARTON (71288-132-90) * 15 mL in 1 VIAL, SINGLE-DOSE (71288-130-15) * 10 mL in 1 VIAL, SINGLE-USE (71288-131-10) 1 kit2021-05-280000-00-00NoNoCurrent