cyclophosphamide

Generic: cyclophosphamide

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

cyclophosphamide 500 mg/5mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3528
Product ID 0781-3528_3a7a4ad7-90ca-4d84-92f1-c61032067deb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217150
Listing Expiration 2026-12-31
Marketing Start 2024-04-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813528
Hyphenated Format 0781-3528

Supplemental Identifiers

RxCUI
2679073
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 NDA217150 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3528-10) / 5 mL in 1 VIAL, MULTI-DOSE (0781-3528-75)
source: ndc

Packages (1)

0781-3528-10 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3528-10) / 5 mL in 1 VIAL, MULTI-DOSE (0781-3528-75)

Ingredients (1)

cyclophosphamide (500 mg/5mL)

Linked Drug Pages (1)

Cyclophosphamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3a7a4ad7-90ca-4d84-92f1-c61032067deb", "openfda": {"unii": ["8N3DW7272P"], "rxcui": ["2679073"], "spl_set_id": ["cf2f4b95-0327-499a-a5a3-51b1bdef68c5"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0781-3528-10)  / 5 mL in 1 VIAL, MULTI-DOSE (0781-3528-75)", "package_ndc": "0781-3528-10", "marketing_start_date": "20240408"}], "brand_name": "Cyclophosphamide", "product_id": "0781-3528_3a7a4ad7-90ca-4d84-92f1-c61032067deb", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "product_ndc": "0781-3528", "generic_name": "Cyclophosphamide", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "500 mg/5mL"}], "application_number": "NDA217150", "marketing_category": "NDA", "marketing_start_date": "20240408", "listing_expiration_date": "20261231"}