bortezomib

Generic: bortezomib

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bortezomib
Generic Name bortezomib
Labeler bluepoint laboratories
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bortezomib 3.5 mg/3.5mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-541
Product ID 68001-541_3b3aa2dc-f2db-2e48-e063-6394a90a41a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209622
Listing Expiration 2026-12-31
Marketing Start 2022-07-31

Pharmacologic Class

Established (EPC)
proteasome inhibitor [epc]
Mechanism of Action
proteasome inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001541
Hyphenated Format 68001-541

Supplemental Identifiers

RxCUI
402243
UPC
0368001541367
UNII
69G8BD63PP
NUI
N0000175604 N0000175075

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bortezomib (source: ndc)
Generic Name bortezomib (source: ndc)
Application Number ANDA209622 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/3.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (68001-541-36) / 3.5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

68001-541-36 1 VIAL, SINGLE-USE in 1 CARTON (68001-541-36) / 3.5 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

bortezomib (3.5 mg/3.5mL)

Linked Drug Pages (1)

Bortezomib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "3b3aa2dc-f2db-2e48-e063-6394a90a41a2", "openfda": {"nui": ["N0000175604", "N0000175075"], "upc": ["0368001541367"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["c6b620c6-f3d6-4ff3-b46a-50a66e6d41dd"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (68001-541-36)  / 3.5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68001-541-36", "marketing_start_date": "20220731"}], "brand_name": "Bortezomib", "product_id": "68001-541_3b3aa2dc-f2db-2e48-e063-6394a90a41a2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "68001-541", "generic_name": "Bortezomib", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/3.5mL"}], "application_number": "ANDA209622", "marketing_category": "ANDA", "marketing_start_date": "20220731", "listing_expiration_date": "20261231"}