FDA.reportPublic FDA data

NDC 39822-0255-01 - CYCLOPHOSPHAMIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
39822-0255
Requested NDC
39822-0255-01
Package NDCs from labels
39822-0255-1, 39822-0255-01
Manufacturer
XGen Pharmaceuticals DJB, Inc.
Effective date
2024-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYCLOPHOSPHAMIDE - XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc.2024-12-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-0255-1CYCLOPHOSPHAMIDE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,504
39822-0255-1CYCLOPHOSPHAMIDE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0255CYCLOPHOSPHAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]4Current NDC, 2 package rows20241222_02e64046-687d-449e-e063-6294a90a6c32.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0255-1EA - Each39822-0255da9293a1-2af2-4027-8bfc-63d46e2077b312024-03-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONSlate Run Pharmaceuticals, LLC20bda486-cb9a-4d67-8c41-50e9fd0664342025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inc.0e9e22fa-178a-42fc-9f82-c303db3b245a2025-03-05Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDESagent Pharmaceuticals329b5a3a-c7b9-4b11-abf0-009719cdfb792025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDECipla USA Inc.0e1cb955-99c8-4fe5-89d1-399c8e52174e2025-01-10Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONHainan Poly Pharm. Co., Ltd.6fde2705-a2d8-4d48-9618-b9d99d0513732025-01-03Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inccf2f4b95-0327-499a-a5a3-51b1bdef68c52024-12-30Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEXGen Pharmaceuticals DJB, Inc.02e64046-687d-449e-e063-6294a90a6c322024-12-20Warnings, Adverse reactionsExact identifier
application number: ANDA211757
ndc (package): 39822-0255-1
ndc (package): 39822-0250-1
ndc (package): 39822-0260-1
ndc (product): 39822-0260
ndc (product): 39822-0255
ndc (product): 39822-0250
ndc11 (package): 39822025501
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
spl id: 29b88d00-eeea-7282-e063-6294a90a4024
spl set id: 02e64046-687d-449e-e063-6294a90a6c32
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAlembic Pharmaceuticals Limited9e699cf7-860e-4c03-9760-0c24d56df2de2024-12-16Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAlembic Pharmaceuticals Inc.3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea12024-12-10Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDENorthStar Rx LLC76f057be-e3da-0a89-e053-2a91aa0a84382024-11-20Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEHikma Pharmaceuticals USA Inc.8135b917-882f-4b4c-99b7-fa8ea54af4bf2024-11-19Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEFresenius Kabi USA, LLC31986d36-a1bf-4903-93a4-ce7386241ba12024-10-09Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAvyxa Pharma, LLC6f593585-e0dd-48bc-bd2b-c6c787e0b98c2024-07-26Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDE INJECTION, SOLUTIONBaxter Healthcare Company34dbffee-80e0-49c3-90e8-95713a0b7fbe2024-04-10Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Corporation769ded74-6186-40a8-8e44-ceff672874512020-08-07Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Companycef038cc-efab-46d9-99c2-95bb11d6c9bc2017-03-15Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe2017-03-15Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.