FDA.reportPublic FDA data

Bendamustine

Product NDC
71288-102
11-digit product format
712880102
Labeler code
71288
Product ID
71288-102_c4d02b46-b7dc-4c54-9f17-49f378437808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bendamustine HCl
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211001
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bendamustine
Listing expiration
2027-12-31

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
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
71288-102-10Bendamustine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110
71288-102-10Bendamustine5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-102-10EA - Each71288-102be86359d-6819-4a05-abc5-8f52e0a4a88c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-102BENDAMUSTINE (BENDAMUSTINE HCL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENDAMUSTINE (BENDAMUSTINE HCL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]9Current NDC, 2 package rows20230608_40f6f58d-d9ac-4f65-9fc7-16984bf1f180.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1805001bendamustine HCl 100 MG InjectionPSN40f6f58d-d9ac-4f65-9fc7-16984bf1f18010
1805007bendamustine HCl 25 MG InjectionPSN40f6f58d-d9ac-4f65-9fc7-16984bf1f18010
1805001bendamustine hydrochloride 100 MG InjectionSCD40f6f58d-d9ac-4f65-9fc7-16984bf1f18010
1805007bendamustine hydrochloride 25 MG InjectionSCD40f6f58d-d9ac-4f65-9fc7-16984bf1f18010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-102-10712880102101 VIAL, SINGLE-DOSE in 1 CARTON (71288-102-10) / 5 mL in 1 VIAL, SINGLE-DOSE2023-06-05NoNoHistorical