FDA.reportPublic FDA data

NDC 10019-925-82 - IFOSFAMIDE

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
10019-925
Requested NDC
10019-925-82
Package NDCs from labels
10019-925-82, 10019-925-01
Manufacturer
Baxter Healthcare Company | Baxter Deutschland GmbH
Effective date
2024-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IFOSFAMIDE - Baxter Healthcare Company | Baxter Deutschland GmbHBaxter Healthcare Company | Baxter Deutschland GmbH2024-12-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-925-01IFOSFAMIDE1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION116
10019-925-82IFOSFAMIDE20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-925IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 2 package rows20250213_91e433a9-6800-43a6-ac13-a49a04a5aecd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-925-01EA - Each10019-925e7d632eb-c7e8-46d5-874f-9c8c6794b82512012-07-24
10019-925-82EA - Each10019-925600cdfb5-36ed-4da8-bc3b-9d156a625de712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IFOSFAMIDEACTIVE INGREDIENTUM20QQM95YIFOSFAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]5
IFOSFAMIDEACTIVE MOIETYUM20QQM95YIFOSFAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]5

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 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IfosfamideIFOSFAMIDE FOR INJECTIONSteriMax Inc.98798c5e-8384-4990-a1b5-60dfb1e667bb2026-09-01Exact identifier
rxcui: 1791593
unii: UM20QQM95Y
IfosfamideIFOSFAMIDEFresenius Kabi USA, LLCa311a947-7b78-4226-bfe0-f4aa0be20e272026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791593
unii: UM20QQM95Y
IFEXIFOSFAMIDEBaxter Healthcare Corporationb7241707-7538-4d1a-91e7-3a25a91e0b9a2024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019763
rxcui: 1791588
rxcui: 1791593
unii: UM20QQM95Y
IFOSFAMIDEIFOSFAMIDEBaxter Healthcare Company91e433a9-6800-43a6-ac13-a49a04a5aecd2024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019763
ndc (package): 10019-926-16
ndc (package): 10019-925-01
ndc (package): 10019-926-02
ndc (package): 10019-925-82
ndc (product): 10019-926
ndc (product): 10019-925
ndc11 (package): 10019092582
rxcui: 1791588
rxcui: 1791593
spl id: d505027a-76e6-49f1-8ed1-3eeffe9a958b
spl set id: 91e433a9-6800-43a6-ac13-a49a04a5aecd
unii: UM20QQM95Y
IFOSFAMIDEIFOSFAMIDEBaxter Healthcare Companyefb1d03b-2d91-406e-8110-d3a58b8fa7cc2024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019763
rxcui: 1791588
rxcui: 1791593
unii: UM20QQM95Y
IfosfamideIFOSFAMIDEHikma Pharmaceuticals USA Inc.c90ab05f-8fe5-437e-a1c0-8b11ef63291e2020-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UM20QQM95Y

Reported adverse events (FAERS/openFDA)#

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