FDA.reportPublic FDA data

NDC 51079-624-84 - Sulfamylon

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
51079-624
Requested NDC
51079-624-84
Package NDCs from labels
51079-624-84, 51079-624-85
Manufacturer
Mylan Institutional Inc.
Effective date
2018-06-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamylon - Mylan Institutional Inc.Mylan Institutional Inc.2018-06-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-624-84EA - Each51079-6245e015398-e341-44bb-8a93-cac68a69bcab12013-08-02
51079-624-85EA - Each51079-62477bc6993-0df0-4672-be85-14db768e87da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAFENIDE ACETATEACTIVE INGREDIENTRQ6LP6Z0WYSULFAMYLON (MAFENIDE ACETATE) POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL INC.]5
MAFENIDEACTIVE MOIETY58447S8P4LSULFAMYLON (MAFENIDE ACETATE) POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL INC.]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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SULFAMYLONMAFENIDE ACETATERising Pharma Holdings, Inc.008eaa23-8f19-4e39-85ff-540c1c834a9e2023-07-03Warnings, Adverse reactionsExact identifier
unii: RQ6LP6Z0WY
c4a0aa6d-4c2a-464f-9822-57ebc8aeae5c570ce479-d902-4394-bbae-41dfe16c54852018-06-13Warnings, Adverse reactionsExact identifier
spl id: c4a0aa6d-4c2a-464f-9822-57ebc8aeae5c
spl set id: 570ce479-d902-4394-bbae-41dfe16c5485

Reported adverse events (FAERS/openFDA)#

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