Olopatadine Hydrochloride

Product NDC
59651-066
11-digit product format
596510066
Labeler code
59651
Product ID
59651-066_e4cc76ae-38fb-4b0d-acb3-9153ad2004fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aurobindo Pharma Limited
Application
ANDA209995
Marketing category
ANDA
Marketing start
2019-04-04
Marketing end
2022-05-31
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 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
59651-066-05ML - Milliliter59651-066f82b7615-96d3-4e98-9db5-bfa4b87dd63a12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-066-05596510066051 BOTTLE in 1 CARTON (59651-066-05) > 2.5 mL in 1 BOTTLE1 bottle2019-04-042022-05-31NoNoCurrent