cyclophosphamide

Generic: cyclophosphamide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS ORAL
Active Ingredients

cyclophosphamide 500 mg/25mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-135
Product ID 65219-135_fadfc813-11a5-415a-9d70-06c579e7619c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204555
Listing Expiration 2026-12-31
Marketing Start 2023-11-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219135
Hyphenated Format 65219-135

Supplemental Identifiers

RxCUI
1734917 1734919 1734921
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 ANDA204555 (source: ndc)
Routes
INTRAVENOUS ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/25mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-135-20) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65219-135-20 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-135-20) / 25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cyclophosphamide (500 mg/25mL)

Linked Drug Pages (1)

Cyclophosphamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "ORAL"], "spl_id": "fadfc813-11a5-415a-9d70-06c579e7619c", "openfda": {"unii": ["8N3DW7272P"], "rxcui": ["1734917", "1734919", "1734921"], "spl_set_id": ["31986d36-a1bf-4903-93a4-ce7386241ba1"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65219-135-20)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65219-135-20", "marketing_start_date": "20231117"}], "brand_name": "Cyclophosphamide", "product_id": "65219-135_fadfc813-11a5-415a-9d70-06c579e7619c", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "product_ndc": "65219-135", "generic_name": "cyclophosphamide", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "500 mg/25mL"}], "application_number": "ANDA204555", "marketing_category": "ANDA", "marketing_start_date": "20231117", "listing_expiration_date": "20261231"}