Eye Itch Relief

Product NDC
0536-1096
11-digit product format
005361096
Labeler code
0536
Product ID
0536-1096_188df731-6f6a-4a79-9464-97d52efd213c
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rugby Laboratories
Application
ANDA077958
Marketing category
ANDA
Marketing start
2016-01-20
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1096-402024-11-15C16284748780-11030e365-177f-111a-e063-dadaa90a10e282a31fcf-b36d-4111-b2bf-6a51a8b6c5da
0536-1096-402024-01-30C16284748780-11030e365-177f-111a-e063-dadaa90a10e282a31fcf-b36d-4111-b2bf-6a51a8b6c5da

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1096-40005361096401 BOTTLE, DROPPER in 1 CARTON (0536-1096-40) > 5 mL in 1 BOTTLE, DROPPER2016-01-200000-00-00NoNoCurrent