Bortezomib

Product NDC
72338-200
11-digit product format
723380200
Labeler code
72338
Product ID
72338-200_c7ce3b3b-d310-47b5-9173-e84abab715f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bortezomib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Waverley Pharma Inc
Application
ANDA211898
Marketing category
ANDA
Marketing start
2018-06-19
Substance
BORTEZOMIB
Active strength
3.5 mg/1
Pharmacologic classes
Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bortezomib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BORTEZOMIB3.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii69G8BD63PP
Rxcui402243

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b069d653-565d-b331-cf82-116aa266aee9Product name420260317
987023d7-918d-4465-be3c-f3f8f784679bProduct name120250318
2cff6375-aa9a-4194-a1db-33f6ed6564f1Product name120230322
f8ade071-6be1-4cb3-a390-e8ba41353f9bProduct name120230322
c3c5823c-3bc3-46c2-bc6a-295b30affa78Product name120230113
6429b384-c989-4e27-bc69-c5e1c7dc2e31Product name120200304
71c1111b-030c-4ada-94cb-bf623cfad8ecProduct name120180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72338-200-01Bortezomib1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,13
72338-200-01Bortezomib1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72338-200BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WAVERLEY PHARMA INC]3Current NDC, 2 package rows20240726_a73d7ea7-d068-4d25-b368-fc3db1898be2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402243bortezomib 3.5 MG InjectionPSNa73d7ea7-d068-4d25-b368-fc3db1898be23
402243bortezomib 3.5 MG InjectionSCDa73d7ea7-d068-4d25-b368-fc3db1898be23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72338-200-01723380200011 VIAL in 1 CARTON (72338-200-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2018-06-19NoNoHistorical