VIVIMUSTA

Product NDC
24338-270
11-digit product format
243380270
Labeler code
24338
Product ID
24338-270_24f87fb8-dc5d-4daf-8afc-047afe1bcfee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENDAMUSTINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA212209
Marketing category
NDA
Marketing start
2025-04-01
Substance
BENDAMUSTINE HYDROCHLORIDE
Active strength
25 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
VIVIMUSTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENDAMUSTINE HYDROCHLORIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii981Y8SX18M
Rxcui1726097, 2622914

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8a9046a-cb9e-4038-9878-7314b52d6527Product name120230919
dd915fc1-21b5-4853-a27d-6a309d663ab6Product name120230913
188c28c4-6cdd-493c-850f-0529f5e5dd03Product name120230912
c9aaa656-9de9-4780-9592-b48e28af9e6eProduct name120180723
c2696876-93f7-42b5-907d-853b57a286f7Product name520180626
7dce4968-39c1-46ed-87ca-cce62b5b5728Product name120151215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-270-01VIVIMUSTA1 in 1 CARTONINJECTION12
24338-270-01VIVIMUSTA4 mL in 1 VIAL, MULTI-DOSEINJECTION42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-270-01ML - Milliliter24338-2705a765ec9-e89e-43d4-8b5f-c2b911f837d512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-270VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE) INJECTION [AZURITY PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250406_4df6548f-c4ad-4eb2-a54f-19766a3d90ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726097bendamustine HCl 25 MG/ML Injectable SolutionPSN4df6548f-c4ad-4eb2-a54f-19766a3d90ca2
2622914VIVIMUSTA 25 MG/ML Injectable SolutionPSN4df6548f-c4ad-4eb2-a54f-19766a3d90ca2
2622914bendamustine hydrochloride 25 MG/ML Injectable Solution [Vivimusta]SBD4df6548f-c4ad-4eb2-a54f-19766a3d90ca2
1726097bendamustine hydrochloride 25 MG/ML Injectable SolutionSCD4df6548f-c4ad-4eb2-a54f-19766a3d90ca2
2622914Vivimusta 25 MG/ML Injectable SolutionSY4df6548f-c4ad-4eb2-a54f-19766a3d90ca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24338-270-01243380270011 VIAL, MULTI-DOSE in 1 CARTON (24338-270-01) / 4 mL in 1 VIAL, MULTI-DOSE2025-04-01NoNoCurrent