FDA.reportPublic FDA data

Zaditor

Product NDC
50090-1037
11-digit product format
500901037
Labeler code
50090
Product ID
50090-1037_06e5bdc8-93d0-4ffd-9349-d0f54cbc8fb3
Type
HUMAN OTC DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA077200
Marketing category
ANDA
Marketing start
2012-12-21
Marketing end
0000-00-00
Substance
KETOTIFEN FUMARATE
Active strength
0 mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
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
50090-1037-02020-01-31C16284748780-19d75b9d0-c616-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1037-0Zaditor5 mL in 1 BOTTLE, DROPPERSOLUTION55
50090-1037-0Zaditor1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1037-0ML - Milliliter50090-103789053b46-4838-46a8-bdee-9ee52ccf463b12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1037ZADITOR (KETOTIFEN FUMARATE) SOLUTION [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20171117_7a00b07f-3bc6-47be-8063-b2b076c69191.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN7a00b07f-3bc6-47be-8063-b2b076c691915
284380Zaditor 0.025 % Ophthalmic SolutionPSN7a00b07f-3bc6-47be-8063-b2b076c691915
284380ketotifen 0.25 MG/ML Ophthalmic Solution [Zaditor]SBD7a00b07f-3bc6-47be-8063-b2b076c691915
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD7a00b07f-3bc6-47be-8063-b2b076c691915
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY7a00b07f-3bc6-47be-8063-b2b076c691915
311237ketotifen 0.025 % Ophthalmic SolutionSY7a00b07f-3bc6-47be-8063-b2b076c691915
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY7a00b07f-3bc6-47be-8063-b2b076c691915
284380Zaditor 0.025 % (ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY7a00b07f-3bc6-47be-8063-b2b076c691915
284380Zaditor 0.25 MG/ML Ophthalmic SolutionSY7a00b07f-3bc6-47be-8063-b2b076c691915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50090-1037-0500901037005 mL in 1 BOTTLE, DROPPER5 mlHistorical