Olopatadine Hydrochloride

Product NDC
60505-0586
11-digit product format
605050586
Labeler code
60505
Product ID
60505-0586_e4bf8746-503f-d01e-23bf-38441a49cb67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA090918
Marketing category
ANDA
Marketing start
2017-12-06
Marketing end
0000-00-00
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0586-4ML - Milliliter60505-05860baeb5b6-06a6-4851-a0a8-91aabf75f59d12018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0586-4605050586041 BOTTLE in 1 CARTON (60505-0586-4) > 2.5 mL in 1 BOTTLE1 bottle2017-12-060000-00-00NoNoCurrent