Eye Itch

Product NDC
41250-302
11-digit product format
412500302
Labeler code
41250
Product ID
41250-302_6374efa7-a338-4672-a6ef-c8e94d2ae240
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
2014-01-23
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
41250-302-012024-01-30C16284748780-11030e365-46bf-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-302-01Eye Itch1 in 1 CARTONSOLUTION/ DROPS18
41250-302-01Eye Itch5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS58

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-302EYE ITCH (KETOTIFEN FUMARATE) SOLUTION/ DROPS [MEIJER DISTRIBUTION INC ]8Legacy NDC, 2 package rows20220211_fc430abb-a2ed-45e5-832a-d40d1882da11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNfc430abb-a2ed-45e5-832a-d40d1882da118
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDfc430abb-a2ed-45e5-832a-d40d1882da118
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYfc430abb-a2ed-45e5-832a-d40d1882da118
311237ketotifen 0.025 % Ophthalmic SolutionSYfc430abb-a2ed-45e5-832a-d40d1882da118
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYfc430abb-a2ed-45e5-832a-d40d1882da118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-302-01412500302011 BOTTLE, DROPPER in 1 CARTON (41250-302-01) > 5 mL in 1 BOTTLE, DROPPER2014-01-230000-00-00NoNoCurrent