bortezomib

Generic: bortezomib

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

Drug Facts

Product Profile

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

bortezomib 3.5 mg/1

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-118
Product ID 71288-118_27f6f56f-fefb-4caf-aee7-9e7e2a9c74f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212958
Marketing Start 2022-07-26
Marketing End 2026-11-19

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 71288118
Hyphenated Format 71288-118

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 ANDA212958 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-118-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-118-10 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-118-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

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": "27f6f56f-fefb-4caf-aee7-9e7e2a9c74f4", "openfda": {"nui": ["N0000175604", "N0000175075"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["322e315f-dd94-475f-94f4-4d86a7eb5590"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-118-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-118-10", "marketing_end_date": "20261119", "marketing_start_date": "20220726"}], "brand_name": "Bortezomib", "product_id": "71288-118_27f6f56f-fefb-4caf-aee7-9e7e2a9c74f4", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "71288-118", "generic_name": "Bortezomib", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/1"}], "application_number": "ANDA212958", "marketing_category": "ANDA", "marketing_end_date": "20261119", "marketing_start_date": "20220726"}