FDA.reportPublic FDA data

NDC 0078-0467-61 - Desferal

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
0078-0467
Requested NDC
0078-0467-61
Package NDCs from labels
0078-0467-61, 0078-0467-91
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2025-06-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Desferal - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2025-06-17HUMAN 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
0078-0467-61Desferal1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,120
0078-0467-91Desferal4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,420

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0467DESFERAL (DEFEROXAMINE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]19Current NDC, Legacy NDC, 2 package rows20240723_a7174843-5965-49fc-b842-f7eff7b48bbc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0467-61EA - Each0078-0467fe219be8-6536-4d13-a82c-1d01fbfff38312013-02-13
0078-0467-91EA - Each0078-0467b260a20c-2728-40fa-872f-66ff7efc01a112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEFEROXAMINE MESYLATEACTIVE INGREDIENTV9TKO7EO6KDESFERAL (DEFEROXAMINE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7
DEFEROXAMINEACTIVE MOIETYJ06Y7MXW4DDESFERAL (DEFEROXAMINE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7

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
DeferoxamineDEFEROXAMINE MESYLATEFresenius Kabi USA, LLCd91e16df-8daa-4cd2-86a2-273eaa2446e02026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 1731350
unii: V9TKO7EO6K
Deferoxamine mesylateDEFEROXAMINE MESYLATEApotex Corp.c99553fb-3fae-b88a-6c2c-efa7520197f92026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 1731350
unii: V9TKO7EO6K
Deferoxamine MesylateDEFEROXAMINE MESYLATEHospira, Inc.f9ab6b1c-98d0-4373-0e9b-b10cb4a675432026-04-06Warnings, Adverse reactionsExact identifier
rxcui: 1731350
unii: V9TKO7EO6K
Deferoxamine mesylateDEFEROXAMINE MESYLATEGland Pharma Limited598fba68-f46e-4b6e-894c-63c2940b20632026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 1731350
unii: V9TKO7EO6K
DesferalDEFEROXAMINE MESYLATEMITEM PHARMA38eff751-96c5-c48a-e063-6294a90a0e482025-07-02Exact identifier
application number: NDA016267
rxcui: 1731352
rxcui: 1731350
unii: V9TKO7EO6K
DesferalDEFEROXAMINE MESYLATENovartis Pharmaceuticals Corporationa7174843-5965-49fc-b842-f7eff7b48bbc2025-06-17Warnings, Adverse reactionsExact identifier
application number: NDA016267
ndc (package): 0078-0467-91
ndc (package): 0078-0467-61
ndc (product): 0078-0467
ndc11 (package): 00078046761
rxcui: 1731352
rxcui: 1731350
spl id: 9f58db85-c282-46eb-94ba-594e2092ddf2
spl set id: a7174843-5965-49fc-b842-f7eff7b48bbc
unii: V9TKO7EO6K

Reported adverse events (FAERS/openFDA)#

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