Ketotifen Fumarate

Product NDC
0363-9060
11-digit product format
003639060
Labeler code
0363
Product ID
0363-9060_904a9117-866f-4edc-9a6a-aa86b7a23a26
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Walgreens
Application
ANDA077958
Marketing category
ANDA
Marketing start
2013-01-25
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
0363-9060-002024-01-30C16284748780-11030e364-fa15-111a-e063-dadaa90a10e21a59d294-5eb4-43e9-b48e-42c4fbd05498

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9060-00Ketotifen Fumarate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS109
0363-9060-00Ketotifen Fumarate1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9060-00ML - Milliliter0363-9060d530bdbb-e4b9-49d8-bc6b-25df4756eefe12015-08-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9060KETOTIFEN FUMARATE SOLUTION/ DROPS [WALGREENS]9Legacy NDC, 2 package rows20220212_1a59d294-5eb4-43e9-b48e-42c4fbd05498.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN1a59d294-5eb4-43e9-b48e-42c4fbd054989
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD1a59d294-5eb4-43e9-b48e-42c4fbd054989
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY1a59d294-5eb4-43e9-b48e-42c4fbd054989
311237ketotifen 0.025 % Ophthalmic SolutionSY1a59d294-5eb4-43e9-b48e-42c4fbd054989
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY1a59d294-5eb4-43e9-b48e-42c4fbd054989

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9060-00003639060001 BOTTLE, DROPPER in 1 CARTON (0363-9060-00) > 10 mL in 1 BOTTLE, DROPPER2013-01-250000-00-00NoNoCurrent