Bortezomib

Product NDC
70511-161
11-digit product format
705110161
Labeler code
70511
Product ID
70511-161_2cc294fe-75e3-4ed9-8259-c6e5bc5e8286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bortezomib
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
MAIA Pharmaceuticals, Inc.
Application
NDA215331
Marketing category
NDA
Marketing start
2022-08-11
Substance
BORTEZOMIB
Active strength
1 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
BORTEZOMIB1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii69G8BD63PP
Rxcui2608948, 2608952

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c3c5823c-3bc3-46c2-bc6a-295b30affa78Product name120230113
6429b384-c989-4e27-bc69-c5e1c7dc2e31Product name120200304
71c1111b-030c-4ada-94cb-bf623cfad8ecProduct name120180108
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70511-161-05Bortezomib1 in 1 VIAL, SINGLE-DOSEINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70511-161BORTEZOMIB INJECTION [MAIA PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20220812_c40e6a28-d577-43d4-bca6-bef28da1d580.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2608948bortezomib 3.5 MG in 1.4 ML InjectionPSNc40e6a28-d577-43d4-bca6-bef28da1d5801
2608952bortezomib 3.5 MG in 3.5 ML InjectionPSNc40e6a28-d577-43d4-bca6-bef28da1d5801
26089481.4 ML bortezomib 2.5 MG/ML InjectionSCDc40e6a28-d577-43d4-bca6-bef28da1d5801
26089523.5 ML bortezomib 1 MG/ML InjectionSCDc40e6a28-d577-43d4-bca6-bef28da1d5801
2608948bortezomib 3.5 MG per 1.4 ML InjectionSYc40e6a28-d577-43d4-bca6-bef28da1d5801
2608952bortezomib 3.5 MG per 3.5 ML InjectionSYc40e6a28-d577-43d4-bca6-bef28da1d5801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70511-161-05705110161051 INJECTION in 1 VIAL, SINGLE-DOSE (70511-161-05) 1 injection2022-08-110000-00-00NoNoCurrent