cyclophosphamide

Generic: cyclophosphamide for injection

Labeler: hainan poly pharm. co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide for injection
Labeler hainan poly pharm. co., ltd.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cyclophosphamide 500 mg/25mL

Manufacturer
Hainan Poly Pharm. Co., Ltd.

Identifiers & Regulatory

Product NDC 14335-470
Product ID 14335-470_2aca7731-9fcc-4625-e063-6394a90a6020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218632
Listing Expiration 2026-12-31
Marketing Start 2025-01-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14335470
Hyphenated Format 14335-470

Supplemental Identifiers

RxCUI
1734917 1734919 1734921
UPC
0314335472013 0314335470019 0314335471016
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 (14335-470-10) / 25 mL in 1 VIAL, SINGLE-DOSE (14335-470-01)
source: ndc

Packages (1)

14335-470-10 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-470-10) / 25 mL in 1 VIAL, SINGLE-DOSE (14335-470-01)

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": "2aca7731-9fcc-4625-e063-6394a90a6020", "openfda": {"upc": ["0314335472013", "0314335470019", "0314335471016"], "unii": ["8N3DW7272P"], "rxcui": ["1734917", "1734919", "1734921"], "spl_set_id": ["6fde2705-a2d8-4d48-9618-b9d99d051373"], "manufacturer_name": ["Hainan Poly Pharm. Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (14335-470-10)  / 25 mL in 1 VIAL, SINGLE-DOSE (14335-470-01)", "package_ndc": "14335-470-10", "marketing_start_date": "20250103"}], "brand_name": "Cyclophosphamide", "product_id": "14335-470_2aca7731-9fcc-4625-e063-6394a90a6020", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "product_ndc": "14335-470", "generic_name": "Cyclophosphamide for Injection", "labeler_name": "Hainan Poly Pharm. Co., Ltd.", "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": "20250103", "listing_expiration_date": "20261231"}