Olopatadine Hydrochloride

Product NDC
65862-757
11-digit product format
658620757
Labeler code
65862
Product ID
65862-757_66c1d070-4b23-4170-b7f3-4b0981f22e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aurobindo Pharma Limited
Application
ANDA204812
Marketing category
ANDA
Marketing start
2015-12-18
Marketing end
2022-05-31
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-757-05ML - Milliliter65862-757749a4985-0bf7-4195-9ca6-370485d78d5612016-01-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-757-05658620757051 BOTTLE in 1 CARTON (65862-757-05) > 5 mL in 1 BOTTLE1 bottle2015-12-182022-05-31NoNoCurrent