FDA.reportPublic FDA data

IVRA

Product NDC
60505-6414
11-digit product format
605056414
Labeler code
60505
Product ID
60505-6414_1aaa2d67-c709-f01c-026d-0eaa8f47c5d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
melphalan HCl
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp
Application
NDA217110
Marketing category
NDA
Marketing start
2025-05-09
Substance
MELPHALAN HYDROCHLORIDE
Active strength
90 mg/mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IVRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELPHALAN HYDROCHLORIDE90 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1VXP4V453T
Rxcui2708998, 2709003

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
60505-6414-1IVRA1 in 1 CARTONINJECTION, SOLUTION15
60505-6414-1IVRA3 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6414-1ML - Milliliter60505-64149a4eb284-17d4-4e30-b9bb-f3e747620e6112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6414IVRA (MELPHALAN HCL) INJECTION, SOLUTION [APOTEX CORP]4Current NDC, 2 package rows20250511_c23e868a-dc62-2181-5099-76c9226602b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709003IVRA 90 MG/ML Injectable SolutionPSNc23e868a-dc62-2181-5099-76c9226602b25
2708998melphalan 90 MG/ML Injectable SolutionPSNc23e868a-dc62-2181-5099-76c9226602b25
2709003melphalan 90 MG/ML Injectable Solution [Ivra]SBDc23e868a-dc62-2181-5099-76c9226602b25
2708998melphalan 90 MG/ML Injectable SolutionSCDc23e868a-dc62-2181-5099-76c9226602b25
2709003Ivra 90 MG (equivalent to melphalan hydrochloride 100.75 MG) per 1 ML Injectable SolutionSYc23e868a-dc62-2181-5099-76c9226602b25
2708998melphalan 90 MG (equivalent to melphalan hydrochloride 100.75 MG) per 1 ML Injectable SolutionSYc23e868a-dc62-2181-5099-76c9226602b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6414-1605056414011 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1) / 3 mL in 1 VIAL, MULTI-DOSE2025-05-09NoNoHistorical