cyclophosphamide

Generic: cyclophosphamide

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide
Labeler bluepoint laboratories
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cyclophosphamide anhydrous 200 mg/mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-564
Product ID 68001-564_3bc6345d-4340-1f0f-e063-6294a90ac0a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212501
Listing Expiration 2026-12-31
Marketing Start 2023-04-10

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001564
Hyphenated Format 68001-564

Supplemental Identifiers

RxCUI
2386859
UPC
0368001564229
UNII
6UXW23996M
NUI
N0000000236 N0000175558

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 NDA212501 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68001-564-22) / 5 mL in 1 VIAL
source: ndc

Packages (1)

68001-564-22 1 VIAL in 1 CARTON (68001-564-22) / 5 mL in 1 VIAL

Ingredients (1)

cyclophosphamide anhydrous (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": "3bc6345d-4340-1f0f-e063-6294a90ac0a9", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0368001564229"], "unii": ["6UXW23996M"], "rxcui": ["2386859"], "spl_set_id": ["0afd2cc7-09e6-481a-afea-9d2e3742da46"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68001-564-22)  / 5 mL in 1 VIAL", "package_ndc": "68001-564-22", "marketing_start_date": "20230410"}], "brand_name": "CYCLOPHOSPHAMIDE", "product_id": "68001-564_3bc6345d-4340-1f0f-e063-6294a90ac0a9", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68001-564", "generic_name": "cyclophosphamide", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOPHOSPHAMIDE", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE ANHYDROUS", "strength": "200 mg/mL"}], "application_number": "NDA212501", "marketing_category": "NDA", "marketing_start_date": "20230410", "listing_expiration_date": "20261231"}