FDA.reportPublic FDA data

NDC 10019-982-09 - 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
10019-982
Requested NDC
10019-982-09
Package NDCs from labels
10019-982-09, 10019-982-01
Manufacturer
Baxter Healthcare Corporation | Baxter Deutschland GmbH
Effective date
2020-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclophosphamide - Baxter Healthcare Corporation | Baxter Deutschland GmbHBaxter Healthcare Corporation | Baxter Deutschland GmbH2020-08-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-982-01Cyclophosphamide1 in 1 CARTONTABLET17
10019-982-09Cyclophosphamide100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-982CYCLOPHOSPHAMIDE TABLET [BAXTER HEALTHCARE COMPANY]5Current NDC, Legacy NDC, 2 package rows20250417_769ded74-6186-40a8-8e44-ceff67287451.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-982-01EA - Each10019-98205217a1b-6b3f-4fed-9227-b1d01f91839212021-04-08
10019-982-09EA - Each10019-982bad2d34f-a70b-4ae6-953d-ad96152a431712021-04-08

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
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
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
application number: NDA012141
ndc (package): 10019-984-01
ndc (package): 10019-984-09
ndc (package): 10019-982-01
ndc (package): 10019-982-09
ndc (product): 10019-982
ndc (product): 10019-984
ndc11 (package): 10019098209
rxcui: 197549
rxcui: 197550
spl id: dc40762e-5ccf-402c-a7b1-4c9dee737811
spl set id: 769ded74-6186-40a8-8e44-ceff67287451
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Companycef038cc-efab-46d9-99c2-95bb11d6c9bc2017-03-15Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe2017-03-15Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P

Reported adverse events (FAERS/openFDA)#

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