Bortezomib

Product NDC
75007-501
11-digit product format
750070501
Labeler code
75007
Product ID
75007-501_1393b9d2-c8d3-49f9-8665-5cc3a083f0c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bortezomib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Ningbo Shuangcheng Pharmaceutical Co., Ltd.
Application
ANDA216528
Marketing category
ANDA
Marketing start
2025-12-17
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402243bortezomib 3.5 MG InjectionPSNb17ca681-59a5-4af7-98a4-953b383798933
402243bortezomib 3.5 MG InjectionSCDb17ca681-59a5-4af7-98a4-953b383798933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75007-501-317500705013110 VIAL in 1 CARTON (75007-501-31) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL10 vial2025-12-17NoNoCurrent
75007-501-32750070501321 VIAL in 1 CARTON (75007-501-32) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2025-12-17NoNoCurrent