FDA.reportPublic FDA data

bendamustine hydrochloride

Product NDC
68001-572
11-digit product format
680010572
Labeler code
68001
Product ID
68001-572_14ca6252-d081-3bdf-e063-6394a90abb8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bendamustine hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA205574
Marketing category
ANDA
Marketing start
2023-09-15
Substance
BENDAMUSTINE HYDROCHLORIDE
Active strength
100 mg/20mL
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 HYDROCHLORIDE100 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii981Y8SX18M
Rxcui1805001, 1805007

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c9aaa656-9de9-4780-9592-b48e28af9e6eProduct name120180723
c2696876-93f7-42b5-907d-853b57a286f7Product name520180626
7dce4968-39c1-46ed-87ca-cce62b5b5728Product name120151215
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-572-41bendamustine hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13
68001-572-41bendamustine hydrochloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-572-41EA - Each68001-57262cf2ef4-0797-4f0f-9771-57956c7a23a712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-572BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]3Current NDC, 2 package rows20240330_0df025d2-c093-427a-b599-f605e71fe835.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1805001bendamustine HCl 100 MG InjectionPSN0df025d2-c093-427a-b599-f605e71fe8353
1805007bendamustine HCl 25 MG InjectionPSN0df025d2-c093-427a-b599-f605e71fe8353
1805001bendamustine hydrochloride 100 MG InjectionSCD0df025d2-c093-427a-b599-f605e71fe8353
1805007bendamustine hydrochloride 25 MG InjectionSCD0df025d2-c093-427a-b599-f605e71fe8353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-572-41680010572411 VIAL, SINGLE-DOSE in 1 CARTON (68001-572-41) / 20 mL in 1 VIAL, SINGLE-DOSE2023-10-15NoNoCurrent