OLOPATADINE HYDROCHLORIDE

Product NDC
50090-3566
11-digit product format
500903566
Labeler code
50090
Product ID
50090-3566_9373fa80-2e97-4f53-ad72-60f5f843a308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA206306
Marketing category
ANDA
Marketing start
2015-12-07
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3566-02024-01-30C16284748780-11030e365-0166-111a-e063-dadaa90a10e2OLOPATADINE Hydrochloride Ophthalmic Solution USP, 0.1% Somerset Therapeutics, LLC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3566-0OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLESOLUTION/ DROPS511
50090-3566-0OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION/ DROPS111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3566-0ML - Milliliter50090-3566ed963337-3bff-48f6-a25a-ef4a4b9b41b312021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3566OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]11Legacy NDC, 2 package rows20220518_994ca5d1-2dd5-4abd-a169-5379efa2a538.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN994ca5d1-2dd5-4abd-a169-5379efa2a53811
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD994ca5d1-2dd5-4abd-a169-5379efa2a53811
1111339olopatadine 0.1 % Ophthalmic SolutionSY994ca5d1-2dd5-4abd-a169-5379efa2a53811
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY994ca5d1-2dd5-4abd-a169-5379efa2a53811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3566-0500903566001 BOTTLE in 1 CARTON (50090-3566-0) > 5 mL in 1 BOTTLE1 bottle2018-08-300000-00-00NoNoCurrent