cyclophosphamide

Generic: cyclophosphamide injection, solution

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide injection, solution
Labeler baxter healthcare company
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cyclophosphamide 200 mg/mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-9777
Product ID 0338-9777_4f8ec65c-284b-4a7e-86d6-d3ced9cef625
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217651
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03389777
Hyphenated Format 0338-9777

Supplemental Identifiers

RxCUI
2386859
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 injection, solution (source: ndc)
Application Number NDA217651 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0338-9777-01) / 2.5 mL in 1 VIAL
source: ndc

Packages (1)

0338-9777-01 1 VIAL in 1 CARTON (0338-9777-01) / 2.5 mL in 1 VIAL

Ingredients (1)

cyclophosphamide (200 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": "4f8ec65c-284b-4a7e-86d6-d3ced9cef625", "openfda": {"unii": ["8N3DW7272P"], "rxcui": ["2386859"], "spl_set_id": ["34dbffee-80e0-49c3-90e8-95713a0b7fbe"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0338-9777-01)  / 2.5 mL in 1 VIAL", "package_ndc": "0338-9777-01", "marketing_start_date": "20240801"}], "brand_name": "Cyclophosphamide", "product_id": "0338-9777_4f8ec65c-284b-4a7e-86d6-d3ced9cef625", "dosage_form": "INJECTION", "product_ndc": "0338-9777", "generic_name": "cyclophosphamide injection, solution", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "200 mg/mL"}], "application_number": "NDA217651", "marketing_category": "NDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}