Olopatadine

Product NDC
50090-3552
11-digit product format
500903552
Labeler code
50090
Product ID
50090-3552_e2c42375-fe9a-4d63-afc2-aab3e0c1df03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA204532
Marketing category
ANDA
Marketing start
2017-01-10
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3552-0Olopatadine1 in 1 CARTONSOLUTION/ DROPS16
50090-3552-0Olopatadine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3552-0ML - Milliliter50090-3552a7e52e2f-2719-48fe-8236-86f5272c6f7e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3552OLOPATADINE (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210417_9da48944-4d1b-4357-9f39-175e2ba674eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN9da48944-4d1b-4357-9f39-175e2ba674eb6
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD9da48944-4d1b-4357-9f39-175e2ba674eb6
1111339olopatadine 0.1 % Ophthalmic SolutionSY9da48944-4d1b-4357-9f39-175e2ba674eb6
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY9da48944-4d1b-4357-9f39-175e2ba674eb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3552-0500903552001 BOTTLE, DROPPER in 1 CARTON (50090-3552-0) > 5 mL in 1 BOTTLE, DROPPER2018-08-240000-00-00NoNoCurrent