FDA.reportPublic FDA data

NDC 11980-074-05 - HMS

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
11980-074
Requested NDC
11980-074-05
Package NDCs from labels
11980-074-05, 11980-074-10
Manufacturer
Allergan, Inc.
Effective date
2006-02-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HMS ® (medrysone ophthalmic suspension) 1%Allergan, Inc.2006-02-28HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11980-074-05HMS5 mL in 1 BOTTLESUSPENSION51
11980-074-10HMS10 mL in 1 BOTTLESUSPENSION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11980-074HMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]12 package rows20060821_1612d931-d86e-4dba-bbd7-0aac3eaee131.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MedrysoneACTIVE INGREDIENTD2UFC189XFHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
MedrysoneACTIVE MOIETYD2UFC189XFHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
benzalkonium chlorideINACTIVE INGREDIENTHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
hypromelloseINACTIVE INGREDIENTHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
polyvinyl alcoholINACTIVE INGREDIENTHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
potassium chlorideINACTIVE INGREDIENT660YQ98I10HMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74HMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RHMS (MEDRYSONE) SUSPENSION [ALLERGAN, INC.]1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B08BDAA0-28F1-6D59-3526-C965D2DB1A6F1612d931-d86e-4dba-bbd7-0aac3eaee1312006-02-28Warnings, Adverse reactionsExact identifier
spl id: B08BDAA0-28F1-6D59-3526-C965D2DB1A6F
spl set id: 1612d931-d86e-4dba-bbd7-0aac3eaee131

Reported adverse events (FAERS/openFDA)#

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