FDA.reportPublic FDA data

BORTEZOMIB

Product NDC
10019-991
11-digit product format
100190991
Labeler code
10019
Product ID
10019-991_d8d0b49f-bf01-47f6-9e7a-40f203f95f28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bortezomib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA213823
Marketing category
ANDA
Marketing start
2022-05-02
Marketing end
0000-00-00
Substance
BORTEZOMIB
Active strength
4 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10019-991DDiscontinued by firm2026-08-03
excluded packagepackage10019-99110019-991-01DDiscontinued by firm2026-08-03

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213823-001BORTEZOMIBBORTEZOMIB3.5MG/VIALINJECTABLE / INTRAVENOUS, SUBCUTANEOUS2022-05-02

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213823-001BORTEZOMIB3.5MG/VIALINJECTABLE / INTRAVENOUS, SUBCUTANEOUS2022-05-02a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-991-01EA - Each10019-9910a261169-7af1-4600-9888-e33677c8d5f012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-991BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]7Legacy NDC20250209_5ba41024-53f5-40a1-88c7-591d588599b7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10019-991-01100190991011 VIAL, SINGLE-DOSE in 1 CARTON (10019-991-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2022-05-020000-00-00NoNoCurrent