bortezomib

Generic: bortezomib

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bortezomib
Generic Name bortezomib
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bortezomib 1 mg/1

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-650
Product ID 68083-650_81bfe4b3-5e07-442f-9351-f521de933404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219167
Listing Expiration 2027-12-31
Marketing Start 2026-01-06

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 68083650
Hyphenated Format 68083-650

Supplemental Identifiers

RxCUI
2601542 2601544
UPC
0368083650018
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 ANDA219167 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-650-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-650-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-650-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bortezomib (1 mg/1)

Linked Drug Pages (1)

Bortezomib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "81bfe4b3-5e07-442f-9351-f521de933404", "openfda": {"nui": ["N0000175604", "N0000175075"], "upc": ["0368083650018"], "unii": ["69G8BD63PP"], "rxcui": ["2601542", "2601544"], "spl_set_id": ["cd698074-da21-4b53-8f6b-241535a8d598"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-650-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-650-01", "marketing_start_date": "20260106"}], "brand_name": "Bortezomib", "product_id": "68083-650_81bfe4b3-5e07-442f-9351-f521de933404", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "68083-650", "generic_name": "Bortezomib", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "1 mg/1"}], "application_number": "ANDA219167", "marketing_category": "ANDA", "marketing_start_date": "20260106", "listing_expiration_date": "20271231"}