FDA.reportPublic FDA data

Bendamustine Hydrochloride

Product NDC
60505-6228
11-digit product format
605056228
Labeler code
60505
Product ID
60505-6228_5ebe4a1f-c7d6-95a3-8f21-8deebf9bd43a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bendamustine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp
Application
NDA215033
Marketing category
NDA
Marketing start
2023-04-26
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
Bendamustine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENDAMUSTINE HYDROCHLORIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii981Y8SX18M
Rxcui1726097

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
60505-6228-0Bendamustine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION18
60505-6228-0Bendamustine Hydrochloride5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6228-0ML - Milliliter60505-6228a1d93414-2782-4f42-8222-b9ad0b76380912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6228BENDAMUSTINE HYDROCHLORIDE INJECTION, SOLUTION [APOTEX CORP]7Current NDC, 2 package rows20240413_085dd54c-4212-d879-afef-ee52732a48c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726097bendamustine HCl 25 MG/ML Injectable SolutionPSN085dd54c-4212-d879-afef-ee52732a48c08
1726097bendamustine hydrochloride 25 MG/ML Injectable SolutionSCD085dd54c-4212-d879-afef-ee52732a48c08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6228-0605056228001 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 mL in 1 VIAL, MULTI-DOSE2023-04-26NoNoCurrent