Bortezomib

Product NDC
72205-183
11-digit product format
722050183
Labeler code
72205
Product ID
72205-183_d41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bortezomib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA209622
Marketing category
ANDA
Marketing start
2022-07-26
Substance
BORTEZOMIB
Active strength
3.5 mg/3.5mL
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/3.5mL

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
72205-183-01Bortezomib1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
72205-183-01Bortezomib3.5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-183-01EA - Each72205-1839876df96-fe9d-4b26-b6d8-b9f7419f36ab12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-183BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20220728_d41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402243bortezomib 3.5 MG InjectionPSNd41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e1
402243bortezomib 3.5 MG InjectionSCDd41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-183-01722050183011 VIAL, SINGLE-USE in 1 CARTON (72205-183-01) / 3.5 mL in 1 VIAL, SINGLE-USE2022-07-270000-00-00NoNoCurrent