Bortezomib

Product NDC
72266-243
Requested package NDC
72266-243-01
11-digit product format
722660243
Labeler code
72266
Product ID
72266-243_e6718dc6-ebc8-570b-e053-2a95a90a86ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bortezomib
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
FOSUN PHARMA USA INC
Application
NDA215331
Marketing category
NDA
Marketing start
2022-08-23
Marketing end
0000-00-00
Substance
BORTEZOMIB
Active strength
1 mg/1
Pharmacologic classes
Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72266-24372266-243-01DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215331-001BORTEZOMIBBORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27
N215331-002BORTEZOMIBBORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215331-001116791192042-09-23U-36322023-06-27
N215331-001116791192042-09-23U-36332023-06-27
N215331-001117521642042-09-23U-36322023-09-28
N215331-001117521642042-09-23U-36332023-09-28
N215331-001120050692042-09-23Drug product2024-06-20
N215331-002116791192042-09-23U-36322023-06-27
N215331-002116791192042-09-23U-36332023-06-27
N215331-002117521642042-09-23U-36322023-09-28
N215331-002117521642042-09-23U-36332023-09-28
N215331-002120050692042-09-23Drug product2024-06-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-278072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-279b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-07-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215331-001BORTEZOMIB3.5MG/3.5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2022-07-27a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215331-002BORTEZOMIB3.5MG/1.4ML (2.5MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-07-27a67488948f0b…

Observed Orange Book patent history#

Patent history page 1 of 5 · 190 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215331-001116791192042-09-23U-36322023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-001116791192042-09-23U-36332023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-001117521642042-09-23U-36322023-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-001117521642042-09-23U-36332023-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-001120050692042-09-23Drug product2024-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-002116791192042-09-23U-36322023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-002116791192042-09-23U-36332023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-002117521642042-09-23U-36322023-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-002117521642042-09-23U-36332023-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215331-002120050692042-09-23Drug product2024-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-001116791192042-09-23U-36322023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-001116791192042-09-23U-36332023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-001117521642042-09-23U-36322023-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-001117521642042-09-23U-36332023-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-001120050692042-09-23Drug product2024-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-002116791192042-09-23U-36322023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-002116791192042-09-23U-36332023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-002117521642042-09-23U-36322023-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-002117521642042-09-23U-36332023-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215331-002120050692042-09-23Drug product2024-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N215331-001116791192042-09-23U-36322023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-001116791192042-09-23U-36332023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-001117521642042-09-23U-36322023-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-001117521642042-09-23U-36332023-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-001120050692042-09-23Drug product2024-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-002116791192042-09-23U-36322023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-002116791192042-09-23U-36332023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-002117521642042-09-23U-36322023-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-002117521642042-09-23U-36332023-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215331-002120050692042-09-23Drug product2024-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-001116791192042-09-23U-36322023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-001116791192042-09-23U-36332023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-001117521642042-09-23U-36322023-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-001117521642042-09-23U-36332023-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-001120050692042-09-23Drug product2024-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-002116791192042-09-23U-36322023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-002116791192042-09-23U-36332023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-002117521642042-09-23U-36322023-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-002117521642042-09-23U-36332023-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215331-002120050692042-09-23Drug product2024-06-20fd3edfee7708…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BortezomibBORTEZOMIBMAIA Pharmaceuticals, Inc.c40e6a28-d577-43d4-bca6-bef28da1d5802021-09-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 215331
application number: NDA215331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-243-01722660243011 INJECTION in 1 VIAL, SINGLE-DOSE (72266-243-01) 1 injection2022-08-230000-00-00NoNoCurrent