FDA.reportPublic FDA data

Ketotifen Fumarate Ophthalmic Solution

Product NDC
72485-617
11-digit product format
724850617
Labeler code
72485
Product ID
72485-617_cd02d900-5bfc-494b-a588-8f6098fe058e
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA077958
Marketing category
ANDA
Marketing start
2023-10-09
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
Ketotifen Fumarate Ophthalmic Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOTIFEN FUMARATE.25 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-617-10Ketotifen Fumarate Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS14
72485-617-10Ketotifen Fumarate Ophthalmic Solution5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-617KETOTIFEN FUMARATE OPHTHALMIC SOLUTION (KETOTIFEN FUMARATE) SOLUTION/ DROPS [ARMAS PHARMACEUTICALS INC.]4Current NDC, 2 package rows20240102_b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNb1ea15a5-5354-4086-a22d-cc1b3e0e1eb34
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDb1ea15a5-5354-4086-a22d-cc1b3e0e1eb34
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYb1ea15a5-5354-4086-a22d-cc1b3e0e1eb34
311237ketotifen 0.025 % Ophthalmic SolutionSYb1ea15a5-5354-4086-a22d-cc1b3e0e1eb34
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYb1ea15a5-5354-4086-a22d-cc1b3e0e1eb34
311237ketotifen 0.025 % Ophthalmic SolutionPSNf4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c2
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDf4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c2
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYf4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c2
311237ketotifen 0.025 % Ophthalmic SolutionSYf4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c2
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYf4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72485-617-10724850617101 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 5 mL in 1 BOTTLE, DROPPER2023-10-09NoNoCurrent