Bortezomib

Product NDC
67184-0530
11-digit product format
671840530
Labeler code
67184
Product ID
67184-0530_7f2d7d7b-99b3-4b68-9bbd-89a8249c66a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bortezomib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA210824
Marketing category
ANDA
Marketing start
2022-05-02
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
67184-0530-1Bortezomib1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
67184-0530-1Bortezomib1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0530BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]1Current NDC, Legacy NDC, 2 package rows20220510_aef02171-bf8a-43ad-b40c-7642623f9802.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402243bortezomib 3.5 MG InjectionPSNaef02171-bf8a-43ad-b40c-7642623f98021
402243bortezomib 3.5 MG InjectionSCDaef02171-bf8a-43ad-b40c-7642623f98021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67184-0530-1671840530011 in 1 CARTONHistorical