FDA.reportPublic FDA data

BORTEZOMIB

Product NDC
25021-262
11-digit product format
250210262
Labeler code
25021
Product ID
25021-262_17982e48-31b2-4b74-896f-b7f61b1e54ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BORTEZOMIB
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA210824
Marketing category
ANDA
Marketing start
2025-05-15
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
25021-262-10BORTEZOMIB1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
25021-262-10BORTEZOMIB1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-262-10EA - Each25021-2627c661366-27f8-4dff-8b04-cf75bf4c012312025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-262BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20250522_945fbaf0-7a79-4676-aa90-e9a213c0654f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402243bortezomib 3.5 MG InjectionPSN945fbaf0-7a79-4676-aa90-e9a213c0654f1
402243bortezomib 3.5 MG InjectionSCD945fbaf0-7a79-4676-aa90-e9a213c0654f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-262-10250210262101 VIAL in 1 CARTON (25021-262-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2025-05-15NoNoHistorical