bortezomib

Generic: bortezomib

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bortezomib
Generic Name bortezomib
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bortezomib 3.5 mg/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-821
Product ID 63323-821_f82298bb-9017-4d5b-ada9-3d34e46d18f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209659
Listing Expiration 2026-12-31
Marketing Start 2022-05-02

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 63323821
Hyphenated Format 63323-821

Supplemental Identifiers

RxCUI
402243
UPC
0363323821104
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 ANDA209659 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (63323-821-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

63323-821-10 1 VIAL, SINGLE-USE in 1 CARTON (63323-821-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

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": "f82298bb-9017-4d5b-ada9-3d34e46d18f1", "openfda": {"nui": ["N0000175604", "N0000175075"], "upc": ["0363323821104"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["3494c357-a692-4e55-89e1-93532b0baef7"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (63323-821-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "63323-821-10", "marketing_start_date": "20220502"}], "brand_name": "Bortezomib", "product_id": "63323-821_f82298bb-9017-4d5b-ada9-3d34e46d18f1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "63323-821", "generic_name": "Bortezomib", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/1"}], "application_number": "ANDA209659", "marketing_category": "ANDA", "marketing_start_date": "20220502", "listing_expiration_date": "20261231"}