frindovyx

Generic: cyclophosphamide

Labeler: avyxa pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name frindovyx
Generic Name cyclophosphamide
Labeler avyxa pharma, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cyclophosphamide 500 mg/mL

Manufacturer
Avyxa Pharma, LLC

Identifiers & Regulatory

Product NDC 83831-119
Product ID 83831-119_8a1dd776-1219-455e-a47f-bc6fc921c15c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210852
Listing Expiration 2026-12-31
Marketing Start 2025-03-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83831119
Hyphenated Format 83831-119

Supplemental Identifiers

RxCUI
2703027 2703032
UPC
0383831119012 0383831120025
UNII
8N3DW7272P

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 frindovyx (source: ndc)
Generic Name cyclophosphamide (source: ndc)
Application Number NDA210852 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (83831-119-01) / 1 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

83831-119-01 1 VIAL, MULTI-DOSE in 1 CARTON (83831-119-01) / 1 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

cyclophosphamide (500 mg/mL)

Linked Drug Pages (1)

Frindovyx ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8a1dd776-1219-455e-a47f-bc6fc921c15c", "openfda": {"upc": ["0383831119012", "0383831120025"], "unii": ["8N3DW7272P"], "rxcui": ["2703027", "2703032"], "spl_set_id": ["5ad8ea65-4c98-487a-9c8d-df778765ec5e"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (83831-119-01)  / 1 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "83831-119-01", "marketing_start_date": "20250319"}], "brand_name": "Frindovyx", "product_id": "83831-119_8a1dd776-1219-455e-a47f-bc6fc921c15c", "dosage_form": "INJECTION", "product_ndc": "83831-119", "generic_name": "Cyclophosphamide", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Frindovyx", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "500 mg/mL"}], "application_number": "NDA210852", "marketing_category": "NDA", "marketing_start_date": "20250319", "listing_expiration_date": "20261231"}