OLOPATADINE HYDROCHLORIDE

Product NDC
72189-053
11-digit product format
721890053
Labeler code
72189
Product ID
72189-053_9595068f-5a1d-9d7e-e053-2a95a90aaf8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Direct Rx
Application
ANDA204812
Marketing category
ANDA
Marketing start
2019-10-23
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-053-052025-06-10C16284748780-1f386c649-fed9-0266-e053-dadaa90a7c1a9595068f-5a1c-9d7e-e053-2a95a90aaf8b
72189-053-052023-01-30C16284748780-1f386c649-fed9-0266-e053-dadaa90a7c1a9595068f-5a1c-9d7e-e053-2a95a90aaf8b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-053-05ML - Milliliter72189-053a6b825c6-61b1-40fa-bb63-9d261554272412019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-053OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [DIRECT RX]1Legacy NDC20191123_9595068f-5a1c-9d7e-e053-2a95a90aaf8b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-053-05721890053051 mL in 1 BOTTLE (72189-053-05) 1 ml2019-10-230000-00-00NoNoCurrent