FDA.reportPublic FDA data

Bortezomib

Product NDC
72603-270
11-digit product format
726030270
Labeler code
72603
Product ID
72603-270_27ad9395-c6d2-f500-ab18-07278b7c7b0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bortezomib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
NorthStar RxLLC
Application
ANDA202963
Marketing category
ANDA
Marketing start
2024-11-01
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6429b384-c989-4e27-bc69-c5e1c7dc2e31Product name120200304
71c1111b-030c-4ada-94cb-bf623cfad8ecProduct name120180108
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-270-01Bortezomib1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13
72603-270-01Bortezomib1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-270-01EA - Each72603-270a9489ea3-13dd-404f-bbd8-e260ba6053d412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-270BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC]3Current NDC, 2 package rows20250507_3f02670b-5683-780c-9d38-5d8f0ef43a14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402243bortezomib 3.5 MG InjectionPSN3f02670b-5683-780c-9d38-5d8f0ef43a143
402243bortezomib 3.5 MG InjectionSCD3f02670b-5683-780c-9d38-5d8f0ef43a143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-270-01726030270011 VIAL, SINGLE-DOSE in 1 CARTON (72603-270-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2024-11-01NoNoCurrent