bortezomib

Generic: bortezomib

Labeler: shilpa medicare limited
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bortezomib
Generic Name bortezomib
Labeler shilpa medicare limited
Dosage Form INJECTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bortezomib 3.5 mg/1.4mL

Manufacturer
Shilpa Medicare Limited

Identifiers & Regulatory

Product NDC 63759-3032
Product ID 63759-3032_71ebcbb5-31e2-4394-8a38-d833fd3c733a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212782
Listing Expiration 2026-12-31
Marketing Start 2024-09-25

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 637593032
Hyphenated Format 63759-3032

Supplemental Identifiers

RxCUI
2608948
UPC
0363759303212
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 NDA212782 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/1.4mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63759-3032-1 1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bortezomib (3.5 mg/1.4mL)

Linked Drug Pages (1)

Bortezomib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "71ebcbb5-31e2-4394-8a38-d833fd3c733a", "openfda": {"nui": ["N0000175604", "N0000175075"], "upc": ["0363759303212"], "unii": ["69G8BD63PP"], "rxcui": ["2608948"], "spl_set_id": ["61539d49-dc21-4576-8813-4bc8abf3868c"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Shilpa Medicare Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1)  / 1.4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63759-3032-1", "marketing_start_date": "20240925"}], "brand_name": "Bortezomib", "product_id": "63759-3032_71ebcbb5-31e2-4394-8a38-d833fd3c733a", "dosage_form": "INJECTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "63759-3032", "generic_name": "Bortezomib", "labeler_name": "Shilpa Medicare Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bortezomib", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/1.4mL"}], "application_number": "NDA212782", "marketing_category": "NDA", "marketing_start_date": "20240925", "listing_expiration_date": "20261231"}