cyclophosphamide

Generic: cyclophosphamide for injection

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide for injection
Labeler slate run pharmaceuticals, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cyclophosphamide 500 mg/25mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-105
Product ID 70436-105_31c60f0f-f81b-a187-e063-6394a90aa39d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218632
Listing Expiration 2026-12-31
Marketing Start 2025-03-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70436105
Hyphenated Format 70436-105

Supplemental Identifiers

RxCUI
1734917 1734919 1734921
UPC
0370436106806 0370436107803 0370436105809
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 for injection (source: ndc)
Application Number ANDA218632 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/25mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-105-80) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

70436-105-80 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-105-80) / 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"], "spl_id": "31c60f0f-f81b-a187-e063-6394a90aa39d", "openfda": {"upc": ["0370436106806", "0370436107803", "0370436105809"], "unii": ["8N3DW7272P"], "rxcui": ["1734917", "1734919", "1734921"], "spl_set_id": ["20bda486-cb9a-4d67-8c41-50e9fd066434"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70436-105-80)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70436-105-80", "marketing_start_date": "20250326"}], "brand_name": "Cyclophosphamide", "product_id": "70436-105_31c60f0f-f81b-a187-e063-6394a90aa39d", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "product_ndc": "70436-105", "generic_name": "Cyclophosphamide for Injection", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "500 mg/25mL"}], "application_number": "ANDA218632", "marketing_category": "ANDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}