Home NDC 68083-650 Bortezomib
Product NDC 68083-650
11-digit product format 680830650
Labeler code 68083
Product ID 68083-650_81bfe4b3-5e07-442f-9351-f521de933404
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bortezomib
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Gland Pharma Limited
Application ANDA219167
Marketing category ANDA
Marketing start 2026-01-06
Substance BORTEZOMIB
Active strength 1 mg/1
Pharmacologic classes Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219167-001 BORTEZOMIB BORTEZOMIB 1MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06 A219167-002 BORTEZOMIB BORTEZOMIB 2.5MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A219167-001 BORTEZOMIB 1MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219167-002 BORTEZOMIB 2.5MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219167-001 BORTEZOMIB 1MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219167-002 BORTEZOMIB 2.5MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219167-001 BORTEZOMIB 1MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219167-002 BORTEZOMIB 2.5MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2026-01-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Bortezomib
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BORTEZOMIB 1 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2601542 Internal RxNorm lookup 2601544 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 68083-650-01 Bortezomib 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 4 68083-650-01 Bortezomib 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68083-650-01 68083065001 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-650-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2026-01-06 No No Current