FDA.reportPublic FDA data

BENDAMUSTINE HYDROCHLORIDE

Product NDC
55150-391
11-digit product format
551500391
Labeler code
55150
Product ID
55150-391_4357b1f0-fcc2-448a-9580-13b55ba470de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENDAMUSTINE HYDROCHLORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA214739
Marketing category
ANDA
Marketing start
2023-06-05
Substance
BENDAMUSTINE HYDROCHLORIDE
Active strength
25 mg/5mL
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/5mL

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
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
55150-391-01BENDAMUSTINE HYDROCHLORIDE5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52
55150-391-01BENDAMUSTINE HYDROCHLORIDE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-391-01EA - Each55150-391875321c2-28cd-42a3-9db8-1ebb4231c7f612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-391BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]2Current NDC, 2 package rows20230717_dbe34bc1-06b2-493f-8859-e8b143357aa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1805001bendamustine HCl 100 MG InjectionPSNdbe34bc1-06b2-493f-8859-e8b143357aa82
1805007bendamustine HCl 25 MG InjectionPSNdbe34bc1-06b2-493f-8859-e8b143357aa82
1805001bendamustine hydrochloride 100 MG InjectionSCDdbe34bc1-06b2-493f-8859-e8b143357aa82
1805007bendamustine hydrochloride 25 MG InjectionSCDdbe34bc1-06b2-493f-8859-e8b143357aa82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55150-391-01551500391011 VIAL, SINGLE-DOSE in 1 CARTON (55150-391-01) / 5 mL in 1 VIAL, SINGLE-DOSE2023-06-05NoNoCurrent