Eye Itch Relief

Product NDC
37808-802
11-digit product format
378080802
Labeler code
37808
Product ID
37808-802_fd489d14-ac75-415d-9a72-0eeb73e1e58e
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
H E B
Application
ANDA077958
Marketing category
ANDA
Marketing start
2014-02-25
Marketing end
0000-00-00
Substance
KETOTIFEN FUMARATE
Active strength
0 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
37808-802-012024-01-30C16284748780-11030e364-fad9-111a-e063-dadaa90a10e2371c1604-f58d-4be6-b822-89211c9e74c8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-802-01Eye Itch Relief5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54
37808-802-01Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-802EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [H E B]4Legacy NDC, 2 package rows20220126_371c1604-f58d-4be6-b822-89211c9e74c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN371c1604-f58d-4be6-b822-89211c9e74c84
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD371c1604-f58d-4be6-b822-89211c9e74c84
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY371c1604-f58d-4be6-b822-89211c9e74c84
311237ketotifen 0.025 % Ophthalmic SolutionSY371c1604-f58d-4be6-b822-89211c9e74c84
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY371c1604-f58d-4be6-b822-89211c9e74c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-802-01378080802011 BOTTLE, DROPPER in 1 CARTON (37808-802-01) > 5 mL in 1 BOTTLE, DROPPER2014-02-250000-00-00NoNoCurrent