Patanase
NDC Package 54868-6049-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Patanase is olopatadine is used to relieve symptoms of seasonal allergies that occur in the nose, such as runny/itchy/stuffy nose, sneezing, and post-nasal drip. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6049 and is authorized under FDA application NDA021861.

Identification & Billing

NDC Package Code
54868-6049-0
Package Description
240 SPRAY, METERED in 1 BOTTLE
Product Code
54868-6049
11-Digit Billing Format
54868604900
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1797895 - olopatadine HCl 665 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797895 - olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797895 - olopatadine hydrochloride 665 MCG/ACTUAT (equivalent to olopatadine 600 MCG/ACTUAT) Metered Dose Nasal Spray
  • RxCUI: 1797898 - PATANASE 665 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797898 - olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal Spray [PATANASE]

Clinical Specifications

Proprietary Name
Patanase
Dosage Form
-
Usage Information
Olopatadine is used to relieve symptoms of seasonal allergies that occur in the nose, such as runny/itchy/stuffy nose, sneezing, and post-nasal drip. This medication is an antihistamine. It works by blocking certain natural substances called histamines that are responsible for allergic symptoms. Do not use this medication in children younger than 2 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (such as saline nose drops/spray, using a humidifier or infant nasal suction bulb).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021861
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-13-2009
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-6049-0 identifies a specific commercial package of 240 spray, metered in 1 bottle of Patanase, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on July 13, 2009. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Olopatadine is used to relieve symptoms of seasonal allergies that occur in the nose, such as runny/itchy/stuffy nose, sneezing, and post-nasal drip. This medication is an antihistamine. It works by blocking certain natural substances called histamines that are responsible for allergic symptoms. Do not use this medication in children younger than 2 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (such as saline nose drops/spray, using a humidifier or infant nasal suction bulb).

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868604900. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
54868-6049-0
11-Digit CMS (5-4-2)
54868-6049-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.