Olopatadine Hydrochloride

Product NDC
68788-7301
11-digit product format
687887301
Labeler code
68788
Product ID
68788-7301_d5595f5c-22cf-4cff-b43d-72877b5f3c62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078350
Marketing category
ANDA
Marketing start
2019-01-02
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7301-5ML - Milliliter68788-7301a0b46f86-5800-4c11-b6c6-8e259faf0fb312019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7301-5687887301051 BOTTLE, PLASTIC in 1 CARTON (68788-7301-5) > 5 mL in 1 BOTTLE, PLASTIC2019-01-020000-00-00NoNoCurrent