1. Home
  2. Labeler Index
  3. Padagis Israel Pharmaceuticals Ltd
  4. 45802-104
  5. NDC Package Code: 45802-104-01 Olopatadine Hydrochloride

NDC Package 45802-104-01 Olopatadine Hydrochloride

Spray Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
45802-104-01
Package Description:
1 BOTTLE in 1 CARTON / 240 SPRAY in 1 BOTTLE
Product Code:
45802-104
Proprietary Name:
Olopatadine Hydrochloride
Non-Proprietary Name:
Olopatadine Hydrochloride
Substance Name:
Olopatadine Hydrochloride
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.
11-Digit NDC Billing Format:
45802010401
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • OLOPATADINE HYDROCHLORIDE 665 ug/1
    • Pharmacologic Class(es):
  • Decreased Histamine Release - [PE] (Physiologic Effect)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Histamine-1 Receptor Inhibitor - [EPC] (Established Pharmacologic Class)
  • Mast Cell Stabilizer - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202853
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-14-2017
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 45802-104-01?

    The NDC Packaged Code 45802-104-01 is assigned to a 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. The product's dosage form is spray and is administered via nasal form.

    Is NDC 45802-104 included in the NDC Directory?

    Yes, Olopatadine Hydrochloride with product code 45802-104 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on June 14, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 45802-104-01?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight.

    What is the 11-digit format for NDC 45802-104-01?

    The 11-digit format is 45802010401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-245802-104-015-4-245802-0104-01