NDC 0998-0522 - Isopto Cetamide

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
0998-0522
Package NDCs from labels
0998-0522-05, 0998-0522-15
Manufacturer
Alcon
Effective date
2006-11-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isopto Cetamide - AlconAlcon2006-11-20Human Prescription Drug Label
Isopto Cetamide® (sulfacetamide sodium ophthalmic solution, USP) 15% SterileALCON INC.2006-07-03Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0998-0522-05Isopto Cetamide5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS51
0998-0522-15Isopto Cetamide15 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS151
0998-0522-15Isopto Cetamide15 mL in 1 BOTTLE, PLASTICSOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0998-0522ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]11 package rows20080313_9ac30a78-6633-4d8d-919e-39f665eb3fdb.zip
0998-0522ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]12 package rows20080313_5a5d8fee-b42a-4f0c-a508-75c7c71bedb4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
sulfacetamideACTIVE MOIETY4965G3J0F5ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
sulfacetamideACTIVE MOIETY4965G3J0F5ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
anhydrous liquid lanolinINACTIVE INGREDIENTISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
dibasic sodium phosphateINACTIVE INGREDIENTGR686LBA74ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
dibasic sodium phosphateINACTIVE INGREDIENTGR686LBA74ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
hydroxypropyl methylcellulose 2910INACTIVE INGREDIENTISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
hydroxypropyl methylcellulose 2910INACTIVE INGREDIENTISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
mineral oilINACTIVE INGREDIENTISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
monobasic sodium phosphateINACTIVE INGREDIENT3980JIH2SWISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
monobasic sodium phosphateINACTIVE INGREDIENT3980JIH2SWISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
sodium thiosulfateINACTIVE INGREDIENTHX1032V43MISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
sodium thiosulfateINACTIVE INGREDIENTHX1032V43MISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
waterINACTIVE INGREDIENT059QF0KO0RISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
waterINACTIVE INGREDIENT059QF0KO0RISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION [ALCON INC.]1
white petrolatumINACTIVE INGREDIENT4T6H12BN9UISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]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
84A47EB2-333C-DEA1-411F-D581395DE84C9ac30a78-6633-4d8d-919e-39f665eb3fdb2006-07-03Warnings, Adverse reactionsExact identifier
spl id: 84A47EB2-333C-DEA1-411F-D581395DE84C
spl set id: 9ac30a78-6633-4d8d-919e-39f665eb3fdb

Reported adverse events (FAERS/openFDA)#

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