bortezomib

Generic: bortezomib

Labeler: sintetica us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

bortezomib 3.5 mg/3.5mL

Manufacturer
Sintetica US LLC

Identifiers & Regulatory

Product NDC 83090-008
Product ID 83090-008_074a288f-8a8f-7c41-e063-6294a90a68dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209622
Listing Expiration 2026-12-31
Marketing Start 2023-07-15

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 83090008
Hyphenated Format 83090-008

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 ANDA209622 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/3.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-008-01) / 3.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83090-008-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-008-01) / 3.5 mL in 1 VIAL, SINGLE-DOSE

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": "074a288f-8a8f-7c41-e063-6294a90a68dc", "openfda": {"nui": ["N0000175604", "N0000175075"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["d79a71ec-b46d-4961-ad05-8980915cba94"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Sintetica US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83090-008-01)  / 3.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83090-008-01", "marketing_start_date": "20230715"}], "brand_name": "Bortezomib", "product_id": "83090-008_074a288f-8a8f-7c41-e063-6294a90a68dc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "83090-008", "generic_name": "Bortezomib", "labeler_name": "Sintetica US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/3.5mL"}], "application_number": "ANDA209622", "marketing_category": "ANDA", "marketing_start_date": "20230715", "listing_expiration_date": "20261231"}