FDA.reportPublic FDA data

Eye Itch Relief

Product NDC
70000-0124
11-digit product format
700000124
Labeler code
70000
Product ID
70000-0124_0c2e7ac9-3977-48ba-995c-004dba0d0ad5
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
ANDA077958
Marketing category
ANDA
Marketing start
2017-01-18
Marketing end
2028-03-31
Substance
KETOTIFEN FUMARATE
Active strength
.35 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eye Itch Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHBD503WORO
Rxcui311237

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
70000-0124-12025-09-22C16284748780-11030e365-6804-111a-e063-dadaa90a10e2add414c5-b6c5-4bb5-8d8a-ddc507a27131
70000-0124-12024-01-30C16284748780-11030e365-6804-111a-e063-dadaa90a10e2add414c5-b6c5-4bb5-8d8a-ddc507a27131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0124-1Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS15
70000-0124-1Eye Itch Relief5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0124-1ML - Milliliter70000-012486a94ee5-57b2-4a27-aae9-2b58ad7393ef12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0124EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CARDINAL HEALTH]4Current NDC, Legacy NDC, 2 package rows20220126_add414c5-b6c5-4bb5-8d8a-ddc507a27131.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNadd414c5-b6c5-4bb5-8d8a-ddc507a271315
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDadd414c5-b6c5-4bb5-8d8a-ddc507a271315
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYadd414c5-b6c5-4bb5-8d8a-ddc507a271315
311237ketotifen 0.025 % Ophthalmic SolutionSYadd414c5-b6c5-4bb5-8d8a-ddc507a271315
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYadd414c5-b6c5-4bb5-8d8a-ddc507a271315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0124-1700000124011 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPER2017-01-182028-03-31NoNoCurrent