Olopatadine Hydrochloride Spray
NDC Package 45802-104-01

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

Package Information

Olopatadine Hydrochloride sprays is olopatadine hydrochloride nasal solution (nasal spray) is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older. This formulation utilizes a spray delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-104 and is authorized under FDA application ANDA202853.

Identification & Billing

NDC Package Code
45802-104-01
Package Description
1 BOTTLE in 1 CARTON / 240 SPRAY in 1 BOTTLE
Product Code
45802-104
11-Digit Billing Format
45802010401
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

Clinical Specifications

Proprietary Name
Olopatadine Hydrochloride
Non-Proprietary Name
Olopatadine Hydrochloride
Substance Name
Olopatadine Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
OLOPATADINE HYDROCHLORIDE 665 ug/1
Pharmacologic Class
Usage Information
Olopatadine hydrochloride nasal solution (nasal spray) is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA202853
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-14-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 45802-104-01 identifies a specific commercial package of 1 bottle in 1 carton / 240 spray in 1 bottle of Olopatadine Hydrochloride, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This spray is formulated for nasal use and contains olopatadine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Israel Pharmaceuticals Ltd on June 14, 2017. The current certification is valid through December 31, 2026.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802010401. 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 (5-3-2)
45802-104-01
11-Digit CMS (5-4-2)
45802-0104-01

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