FDA.reportPublic FDA data

Zaditor

Product NDC
0065-4011
11-digit product format
000654011
Labeler code
0065
Product ID
0065-4011_bed738a0-2943-46e7-a65e-2440dac7971b
Type
HUMAN OTC DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
ANDA077200
Marketing category
ANDA
Marketing start
2013-01-08
Substance
KETOTIFEN FUMARATE
Active strength
.25 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zaditor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOTIFEN FUMARATE.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHBD503WORO
Rxcui284380, 311237

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-4011-05Zaditor1 in 1 CARTONSOLUTION113
0065-4011-05Zaditor5 mL in 1 BOTTLE, DROPPERSOLUTION513
0065-4011-06Zaditor5 mL in 1 BOTTLE, DROPPERSOLUTION513
0065-4011-06Zaditor2 in 1 CARTONSOLUTION213
0065-4011-11Zaditor3 in 1 CARTONSOLUTION313
0065-4011-11Zaditor5 mL in 1 BOTTLE, DROPPERSOLUTION513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-4011-05ML - Milliliter0065-4011d2e44039-5e3f-41fc-8e6d-295be35be56f12013-06-04
0065-4011-06ML - Milliliter0065-401193506bc4-71c8-42e1-8d9b-cc40360ee64312014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ketotifen FumarateACTIVE INGREDIENTHBD503WOROZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]2
KetotifenACTIVE MOIETYX49220T18GZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]2
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-4011ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]13Current NDC, Legacy NDC, 6 package rows20231216_ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
284380Zaditor 0.025 % Ophthalmic SolutionPSNac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
284380ketotifen 0.25 MG/ML Ophthalmic Solution [Zaditor]SBDac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
311237ketotifen 0.025 % Ophthalmic SolutionSYac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
284380Zaditor 0.025 % (ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
284380Zaditor 0.25 MG/ML Ophthalmic SolutionSYac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f13
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-4011-05000654011051 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER2013-03-130000-00-00NoNoCurrent
0065-4011-06000654011062 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER2013-01-080000-00-00NoNoCurrent
0065-4011-11000654011113 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER2015-02-130000-00-00NoNoCurrent