Olopatadine

Product NDC
50090-3489
11-digit product format
500903489
Labeler code
50090
Product ID
50090-3489_1a8dfd8c-6be5-4bc2-b8ff-2070e71d0c13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA204723
Marketing category
ANDA
Marketing start
2017-12-05
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3489-02023-02-07C16284748780-1f386c649-d7ee-0266-e053-dadaa90a7c1a151fd692-a33d-4514-92a6-eb780a1adc97
50090-3489-02023-01-30C16284748780-1f386c649-d7ee-0266-e053-dadaa90a7c1a151fd692-a33d-4514-92a6-eb780a1adc97

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3489-0ML - Milliliter50090-34890841e47a-4c28-4453-b9fa-9e68cb6afedf12021-11-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3489-0500903489001 BOTTLE, DROPPER in 1 CARTON (50090-3489-0) > 2.5 mL in 1 BOTTLE, DROPPER2018-06-180000-00-00NoNoCurrent