bortezomib

Generic: bortezomib

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bortezomib
Generic Name bortezomib
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bortezomib 3.5 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9098
Product ID 0143-9098_e673dbf4-9d4e-4665-ac36-81c6537044fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215011
Listing Expiration 2026-12-31
Marketing Start 2022-07-27

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 01439098
Hyphenated Format 0143-9098

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 ANDA215011 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0143-9098-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

0143-9098-01 1 VIAL in 1 CARTON (0143-9098-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

bortezomib (3.5 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": "e673dbf4-9d4e-4665-ac36-81c6537044fc", "openfda": {"nui": ["N0000175604", "N0000175075"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["854be921-5fd9-482a-8432-a0c0241625f8"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0143-9098-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "0143-9098-01", "marketing_start_date": "20220727"}], "brand_name": "bortezomib", "product_id": "0143-9098_e673dbf4-9d4e-4665-ac36-81c6537044fc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "0143-9098", "generic_name": "bortezomib", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/1"}], "application_number": "ANDA215011", "marketing_category": "ANDA", "marketing_start_date": "20220727", "listing_expiration_date": "20261231"}