FDA.reportPublic FDA data

NDC 10019-939-50 - 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
10019-939
Requested NDC
10019-939-50
Package NDCs from labels
10019-939-50, 10019-939-01
Manufacturer
Baxter Healthcare Company
Effective date
2025-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYCLOPHOSPHAMIDE - Baxter Healthcare CompanyBaxter Healthcare Company2025-06-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-939-01CYCLOPHOSPHAMIDE1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION118
10019-939-50CYCLOPHOSPHAMIDE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION5018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-939CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]14Current NDC, Legacy NDC, 2 package rows20250315_97ab446f-5017-4180-ae65-0a355289b0ed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-939-01EA - Each10019-939ea724ba4-6337-4922-9d31-9cb94f69aab412015-01-05
10019-939-50EA - Each10019-939b1123907-7585-48d7-8077-1bd5afa5770312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOPHOSPHAMIDEACTIVE INGREDIENT8N3DW7272PCYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]2
CYCLOPHOSPHAMIDE ANHYDROUSACTIVE MOIETY6UXW23996MCYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]2

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 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDENexus Pharmaceuticals, LLCc961a1ac-6705-4756-9abc-9d84a6fcb5c82026-09-03Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
FrindovyxCYCLOPHOSPHAMIDEAVYXA Pharma, LLC5ad8ea65-4c98-487a-9c8d-df778765ec5e2026-08-26Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratories1d3396d8-4c03-4a28-890a-d87c6c53a74e2026-03-12Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratoriesd7e97b99-83db-42d0-8521-b87fe6467a672026-02-12Warnings, Adverse reactionsExact identifier
application number: ANDA040745
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAvenacy, LLC1de02105-9c5b-4d11-bddf-bf8450d88b782026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAmneal Pharmaceuticals LLC520bfe39-dfd5-4a20-9a37-80078afded0d2026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBamboo US Bidco LCC2873b99a-830d-0a7b-e063-6394a90a4de72025-12-03Warnings, Adverse reactionsExact identifier
application number: ANDA040745
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEEpic Pharma, LLC988d2f71-1dc7-45b5-b2df-187e682249732025-11-17Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDECivica, Inc.8627c83f-c057-495d-9f78-8b67bda97b3e2025-10-24Warnings, Adverse reactionsExact identifier
application number: ANDA040745
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Company591d9955-3d9c-4cdc-a308-2f1288376b9f2025-06-24Warnings, Adverse reactionsExact identifier
application number: ANDA040745
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company97ab446f-5017-4180-ae65-0a355289b0ed2025-06-20Warnings, Adverse reactionsExact identifier
application number: ANDA040745
ndc (package): 10019-942-10
ndc (package): 10019-938-25
ndc (package): 10019-938-01
ndc (package): 10019-939-50
ndc (package): 10019-939-01
ndc (package): 10019-942-01
ndc (product): 10019-938
ndc (product): 10019-939
ndc (product): 10019-942
ndc11 (package): 10019093950
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
spl id: e478e54f-228b-46a1-9347-df729becf777
spl set id: 97ab446f-5017-4180-ae65-0a355289b0ed
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEEugia US LLC3c1eb470-0bba-457d-94e3-b9508f0d398a2025-04-21Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
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
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAlembic Pharmaceuticals Limited9e699cf7-860e-4c03-9760-0c24d56df2de2024-12-16Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P

Reported adverse events (FAERS/openFDA)#

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