Olopatadine Hydrochloride

Product NDC
60505-0575
11-digit product format
605050575
Labeler code
60505
Product ID
60505-0575_2cc9fdcc-d77c-c800-21e8-36f256dc76de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA078350
Marketing category
ANDA
Marketing start
2015-12-07
Marketing end
0000-00-00
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
1 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
60505-0575-1ML - Milliliter60505-057538f77681-c309-461a-989c-124702a7c09412016-01-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0575-1605050575011 BOTTLE, PLASTIC in 1 CARTON (60505-0575-1) > 5 mL in 1 BOTTLE, PLASTIC2015-12-070000-00-00NoNoCurrent