OLOPATADINE HYDROCHLORIDE

Product NDC
71205-345
11-digit product format
712050345
Labeler code
71205
Product ID
71205-345_662f725b-28ea-4dc5-9a67-586eb1b323af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA206306
Marketing category
ANDA
Marketing start
2016-06-29
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-345OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [PROFICIENT RX LP]3Legacy NDC20221015_3cc3d6f2-cecd-490c-b48c-b605f262c04e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-345-05712050345051 BOTTLE in 1 CARTON (71205-345-05) > 5 mL in 1 BOTTLE1 bottle2019-10-010000-00-00NoNoCurrent