bortezomib

Generic: bortezomib

Labeler: somerset therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bortezomib
Generic Name bortezomib
Labeler somerset therapeutics llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bortezomib 3.5 mg/3.5mL

Manufacturer
Somerset Therapeutics LLC

Identifiers & Regulatory

Product NDC 70069-836
Product ID 70069-836_34c615d6-ddc9-c4b5-e063-6294a90a047f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211898
Listing Expiration 2026-12-31
Marketing Start 2025-04-29

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 70069836
Hyphenated Format 70069-836

Supplemental Identifiers

RxCUI
402243
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 ANDA211898 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/3.5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70069-836-01) / 3.5 mL in 1 VIAL
source: ndc

Packages (1)

70069-836-01 1 VIAL in 1 CARTON (70069-836-01) / 3.5 mL in 1 VIAL

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": "34c615d6-ddc9-c4b5-e063-6294a90a047f", "openfda": {"nui": ["N0000175604", "N0000175075"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["dc737d3d-2a4e-448a-ad70-e013065c411c"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Somerset Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70069-836-01)  / 3.5 mL in 1 VIAL", "package_ndc": "70069-836-01", "marketing_start_date": "20250429"}], "brand_name": "Bortezomib", "product_id": "70069-836_34c615d6-ddc9-c4b5-e063-6294a90a047f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "70069-836", "generic_name": "bortezomib", "labeler_name": "Somerset Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/3.5mL"}], "application_number": "ANDA211898", "marketing_category": "ANDA", "marketing_start_date": "20250429", "listing_expiration_date": "20261231"}