Home NDC 63759-3032 Bortezomib
Product NDC 63759-3032
11-digit product format 637593032
Labeler code 63759
Product ID 63759-3032_71ebcbb5-31e2-4394-8a38-d833fd3c733a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bortezomib
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Shilpa Medicare Limited
Application NDA212782
Marketing category NDA
Marketing start 2024-09-25
Substance BORTEZOMIB
Active strength 3.5 mg/1.4mL
Pharmacologic classes Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212782-001 BORTEZOMIB BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212782-001 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS, SUBCUTANEOUS RLD, RS 2024-08-26 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Bortezomib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BORTEZOMIB 3.5 mg/1.4mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 69G8BD63PP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2608948 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63759-3032-1 Bortezomib 1 in 1 CARTON INJECTION 1 1 63759-3032-1 Bortezomib 1.4 mL in 1 VIAL, SINGLE-DOSE INJECTION 1.4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63759-3032 BORTEZOMIB INJECTION [SHILPA MEDICARE LIMITED] 1 Current NDC, 2 package rows 20240926_61539d49-dc21-4576-8813-4bc8abf3868c.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 63759-3032-1 63759303201 1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE 2024-09-25 No No Current