FDA.reportPublic FDA data

NDC 10019-935-25 - 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
10019-935
Requested NDC
10019-935-25
Package NDCs from labels
10019-935-25, 10019-935-01
Manufacturer
Baxter Healthcare Company
Effective date
2017-03-15
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 Company2017-03-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-935-01CYCLOPHOSPHAMIDE1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION115
10019-935-25CYCLOPHOSPHAMIDE25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-935CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]13Current NDC, Legacy NDC, 2 package rows20250519_6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-935-01EA - Each10019-93506d065ee-5ff3-46e7-86f1-d431b972cc1412015-01-05
10019-935-25EA - Each10019-9357f6341b1-7a18-4715-b5f3-d9fcc4a1672712015-01-05

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
application number: ANDA040745
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe2017-03-15Warnings, Adverse reactionsExact identifier
application number: ANDA040745
ndc (package): 10019-935-25
ndc (package): 10019-937-10
ndc (package): 10019-935-01
ndc (package): 10019-937-01
ndc (package): 10019-936-50
ndc (package): 10019-936-01
ndc (product): 10019-937
ndc (product): 10019-936
ndc (product): 10019-935
ndc11 (package): 10019093525
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
spl id: 9b5bfec0-7b18-4839-b731-53867588ad53
spl set id: 6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe
unii: 8N3DW7272P

Reported adverse events (FAERS/openFDA)#

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