FDA.reportPublic FDA data

Eye Itch Relief

Product NDC
59779-920
11-digit product format
597790920
Labeler code
59779
Product ID
59779-920_47133ae1-e8bb-4c5a-8bab-3c165477b1f1
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CVS Pharmacy
Application
ANDA077958
Marketing category
ANDA
Marketing start
2014-02-07
Marketing end
0000-00-00
Substance
KETOTIFEN FUMARATE
Active strength
0 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-920-012024-01-30C16284748780-11030e365-2f6b-111a-e063-dadaa90a10e22f1f7540-8b6d-4c4f-b86d-4fd35a28f6be

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-920-01Eye Itch Relief2 in 1 CARTONSOLUTION/ DROPS27
59779-920-01Eye Itch Relief5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-920-01ML - Milliliter59779-920cfee905d-8b7d-4480-be1f-c37299425d5312020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketotifen fumarateACTIVE INGREDIENTHBD503WOROEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]1
KetotifenACTIVE MOIETYX49220T18GEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]1
waterINACTIVE INGREDIENT059QF0KO0REYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-920EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]7Legacy NDC, 2 package rows20220211_2f1f7540-8b6d-4c4f-b86d-4fd35a28f6be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN2f1f7540-8b6d-4c4f-b86d-4fd35a28f6be7
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD2f1f7540-8b6d-4c4f-b86d-4fd35a28f6be7
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY2f1f7540-8b6d-4c4f-b86d-4fd35a28f6be7
311237ketotifen 0.025 % Ophthalmic SolutionSY2f1f7540-8b6d-4c4f-b86d-4fd35a28f6be7
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY2f1f7540-8b6d-4c4f-b86d-4fd35a28f6be7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-920-01597790920012 BOTTLE, DROPPER in 1 CARTON (59779-920-01) > 5 mL in 1 BOTTLE, DROPPER2014-02-070000-00-00NoNoCurrent