bortezomib
Generic: bortezomib
Labeler: qilu pharmaceutical co., ltd.Drug Facts
Product Profile
Brand Name
bortezomib
Generic Name
bortezomib
Labeler
qilu pharmaceutical co., ltd.
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
Active Ingredients
bortezomib 3.5 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
67184-0530
Product ID
67184-0530_7f2d7d7b-99b3-4b68-9bbd-89a8249c66a0
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA210824
Listing Expiration
2026-12-31
Marketing Start
2022-05-02
Pharmacologic Class
Established (EPC)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
671840530
Hyphenated Format
67184-0530
Supplemental Identifiers
RxCUI
UPC
UNII
NUI
Packaging Origin
Original Packager
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
ANDA210824 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 3.5 mg/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Bortezomib for Injection is supplied as individually cartoned 10 mL vials containing 3.5 mg of bortezomib as a white to off-white cake or powder. NDC 67184-0530-1 3.5 mg single-dose vial Unopened vials may be stored at controlled room temperature 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light. Follow guidelines for handling and disposal for hazardous drugs, including the use of gloves and other protective clothing to prevent skin contact 1 .
- PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Label NDC 67184-0530-1 Bortezomib for Injection 3.5 mg/vial SINGLE-DOSE VIAL DISCARD UNUSED PORTION FOR INTRAVENOUS OR SUBCUTANEOUS USE PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Label
- PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Carton See Reconstitution Information on Back NDC 67184-0530-1 Bortezomib for Injection 3.5 mg/vial SINGLE-DOSE VIAL – DISCARD UNUSED PORTION FOR INTRAVENOUS OR SUBCUTANEOUS USE PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Carton
- PRINCIPAL DISPLAY PANEL INSIDE FLAP (ALL CARTONS) Reconstitution Information SUBCUTANEOUS INJECTION ONLY 0.9% NaCl Add 1.4 mL 0.9% Sodium Chloride To make 2.5 mg / mL final concentration INTRAVENOUS INJECTION ONLY 0.9% NaCl Add 3.5 mL 0.9% Sodium Chloride To make 1 mg / mL final concentration PRINCIPAL DISPLAY PANEL INSIDE FLAP (ALL CARTONS)
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "7f2d7d7b-99b3-4b68-9bbd-89a8249c66a0", "openfda": {"nui": ["N0000175604", "N0000175075"], "upc": ["0367184053018"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["aef02171-bf8a-43ad-b40c-7642623f9802"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Bortezomib", "product_id": "67184-0530_7f2d7d7b-99b3-4b68-9bbd-89a8249c66a0", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "67184-0530", "generic_name": "Bortezomib", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/1"}], "application_number": "ANDA210824", "marketing_category": "ANDA", "marketing_start_date": "20220502", "listing_expiration_date": "20261231"}