Olopatadine Hydrochloride

Product NDC
68788-7843
11-digit product format
687887843
Labeler code
68788
Product ID
68788-7843_ca868c05-1934-442f-a9a9-0bd2d4933a5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203152
Marketing category
ANDA
Marketing start
2021-01-19
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 Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7843-5ML - Milliliter68788-784316d934e5-7b31-43bd-82da-f52b7f2a74b012021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7843-5687887843055 mL in 1 BOTTLE, DROPPER (68788-7843-5) 5 ml2021-01-190000-00-00NoNoCurrent