Ketotifen Fumarate

Product NDC
70518-2867
11-digit product format
705182867
Labeler code
70518
Product ID
70518-2867_d773e283-0d6f-691a-e053-2a95a90a708c
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
ANDA077354
Marketing category
ANDA
Marketing start
2020-09-04
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
70518-2867-02022-02-07C16284748780-1d6a99b39-c92e-a426-e053-dadaa90af4c2be41b6e2-061f-4d9e-b474-ab9ecf0c9eb0
70518-2867-02022-01-28C16284748780-1d6a99b39-c92e-a426-e053-dadaa90af4c2be41b6e2-061f-4d9e-b474-ab9ecf0c9eb0

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2867-0705182867001 BOTTLE, PLASTIC in 1 CARTON (70518-2867-0) > 5 mL in 1 BOTTLE, PLASTIC2020-09-040000-00-00NoNoCurrent