Itchy Eye

Product NDC
41250-303
11-digit product format
412500303
Labeler code
41250
Product ID
41250-303_095bec2c-97d8-45a3-be5f-e3601c017a6f
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Meijer Distribution Inc
Application
ANDA077958
Marketing category
ANDA
Marketing start
2016-01-26
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
41250-303-012024-01-30C16284748780-11030e365-3f1a-111a-e063-dadaa90a10e211c16152-6feb-45c9-99e3-af514caa2681

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-303-01Itchy Eye1 in 1 CARTONSOLUTION/ DROPS15
41250-303-01Itchy Eye10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-303ITCHY EYE (KETOTIFEN FUMARATE) SOLUTION/ DROPS [MEIJER DISTRIBUTION INC]5Legacy NDC, 2 package rows20220212_11c16152-6feb-45c9-99e3-af514caa2681.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN11c16152-6feb-45c9-99e3-af514caa26815
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD11c16152-6feb-45c9-99e3-af514caa26815
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY11c16152-6feb-45c9-99e3-af514caa26815
311237ketotifen 0.025 % Ophthalmic SolutionSY11c16152-6feb-45c9-99e3-af514caa26815
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY11c16152-6feb-45c9-99e3-af514caa26815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-303-01412500303011 BOTTLE, DROPPER in 1 CARTON (41250-303-01) > 10 mL in 1 BOTTLE, DROPPER2016-01-260000-00-00NoNoCurrent