Eye Itch Relief

Product NDC
50090-7253
11-digit product format
500907253
Labeler code
50090
Product ID
50090-7253_f05216a8-6a4a-401d-ad52-d8ce0a408631
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
NDA021996
Marketing category
NDA
Marketing start
2024-04-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
HBD503WOROKETOTIFEN FUMARATE34580-14-8KETOTIFEN FUMARATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7253-0500907253001 BOTTLE, DROPPER in 1 CARTON (50090-7253-0) / 5 mL in 1 BOTTLE, DROPPER2024-09-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsA-S Medication Solutions2024-10-01HUMAN OTC DRUG LABEL1