NDC 76519-1161 Olopatadine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
76519-1161
Proprietary Name:
Olopatadine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
H.j. Harkins Company, Inc.
Labeler Code:
76519
Start Marketing Date: [9]
10-31-2018
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 76519-1161-0

Package Description: 5 mL in 1 BOTTLE

Product Details

What is NDC 76519-1161?

The NDC code 76519-1161 is assigned by the FDA to the product Olopatadine Hydrochloride which is product labeled by H.j. Harkins Company, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 76519-1161-0 5 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Olopatadine Hydrochloride?

Olopatadine hydrochloride ophthalmic solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

Which are Olopatadine Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Olopatadine Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Olopatadine Ophthalmic


Prescription ophthalmic olopatadine (Pazeo) and nonprescription ophthalmic olopatadine (Pataday) are used to relieve itchy eyes caused by allergic reactions to pollen, ragweed, grass, animal hair, or pet dander. Olopatadine is in a class of medications called mast cell stabilizers. It works by preventing the release of substances that cause eye itching.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".