cyclophosphamide

Generic: cyclophosphamide

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

Drug Facts

Product Profile

Brand Name cyclophosphamide
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 83831-116
Product ID 83831-116_5fc45658-c2d9-41de-821f-ff6f40a469dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210852
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83831116
Hyphenated Format 83831-116

Supplemental Identifiers

RxCUI
2644738 2644751 2644824
UPC
0383831118046 0383831117025 0383831116011
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 cyclophosphamide (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, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83831-116-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cyclophosphamide (500 mg/mL)

Linked Drug Pages (1)

Cyclophosphamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5fc45658-c2d9-41de-821f-ff6f40a469dd", "openfda": {"upc": ["0383831118046", "0383831117025", "0383831116011"], "unii": ["8N3DW7272P"], "rxcui": ["2644738", "2644751", "2644824"], "spl_set_id": ["6f593585-e0dd-48bc-bd2b-c6c787e0b98c"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83831-116-01", "marketing_start_date": "20240801"}], "brand_name": "Cyclophosphamide", "product_id": "83831-116_5fc45658-c2d9-41de-821f-ff6f40a469dd", "dosage_form": "INJECTION", "product_ndc": "83831-116", "generic_name": "Cyclophosphamide", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "500 mg/mL"}], "application_number": "NDA210852", "marketing_category": "NDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}