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  5. NDC Package Code: 57619-303-01 Splash Tears

NDC Package 57619-303-01 Splash Tears

Hypromellose Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
57619-303-01
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code:
57619-303
Proprietary Name:
Splash Tears
Non-Proprietary Name:
Hypromellose
Substance Name:
Hypromellose 2910 (4000 Mpa.s)
Usage Information:
UsesTemporarily relievesburning and irritation due to dryness of the eye.discomfort due to minor irritations of the eye or to exposure to wind or sun.
11-Digit NDC Billing Format:
57619030301
NDC to RxNorm Crosswalk:
  • RxCUI: 359634 - hypromellose 0.2 % Ophthalmic Solution
  • RxCUI: 359634 - hypromellose 2 MG/ML Ophthalmic Solution
  • RxCUI: 359634 - hypromellose 0.2 % Ophthalmic Drops
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Laboratorios Sophia, S.a. De C.v.
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • HYPROMELLOSE 2910 (4000 MPA.S) .2 g/100mL
    • Sample Package:
    No
    FDA Application Number:
    M018
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    05-13-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    57619-303-031 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57619-303-01?

    The NDC Packaged Code 57619-303-01 is assigned to a package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Splash Tears, a human over the counter drug labeled by Laboratorios Sophia, S.a. De C.v.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 57619-303 included in the NDC Directory?

    Yes, Splash Tears with product code 57619-303 is active and included in the NDC Directory. The product was first marketed by Laboratorios Sophia, S.a. De C.v. on May 13, 2020 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 11-digit format for NDC 57619-303-01?

    The 11-digit format is 57619030301. 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
    5-3-257619-303-015-4-257619-0303-01