Ketotifen Fumarate

Product NDC
59779-627
11-digit product format
597790627
Labeler code
59779
Product ID
59779-627_ef62c860-13cf-4f29-871c-4d3b61e8e916
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CVS Pharmacy
Application
ANDA077958
Marketing category
ANDA
Marketing start
2013-11-08
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
59779-627-012024-01-30C16284748780-11030e365-0ae6-111a-e063-dadaa90a10e2f06cf445-b84e-48ad-b30a-046bc8b79284

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-627-01Ketotifen Fumarate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS59
59779-627-01Ketotifen Fumarate1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-627-01ML - Milliliter59779-62753552180-00ae-4df9-a7b5-ef07664b680c12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketotifen fumarateACTIVE INGREDIENTHBD503WOROKETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]4
KetotifenACTIVE MOIETYX49220T18GKETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]4
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7KETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXKETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBKETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IKETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]4
waterINACTIVE INGREDIENT059QF0KO0RKETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-627KETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]9Legacy NDC, 2 package rows20220211_f06cf445-b84e-48ad-b30a-046bc8b79284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNf06cf445-b84e-48ad-b30a-046bc8b792849
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDf06cf445-b84e-48ad-b30a-046bc8b792849
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYf06cf445-b84e-48ad-b30a-046bc8b792849
311237ketotifen 0.025 % Ophthalmic SolutionSYf06cf445-b84e-48ad-b30a-046bc8b792849
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYf06cf445-b84e-48ad-b30a-046bc8b792849

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-627-01597790627011 BOTTLE, DROPPER in 1 CARTON (59779-627-01) > 5 mL in 1 BOTTLE, DROPPER2013-11-080000-00-00NoNoCurrent