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  5. NDC Package Code: 57619-400-01 Manzanilla Sophia

NDC Package 57619-400-01 Manzanilla Sophia

Chamomile (matricaria Chamomilla L.) Solution/ Drops Ophthalmic - 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:
57619-400-01
Package Description:
1 BOTTLE, PLASTIC in 1 PACKAGE / 15 mL in 1 BOTTLE, PLASTIC
Product Code:
57619-400
Proprietary Name:
Manzanilla Sophia
Non-Proprietary Name:
Chamomile (matricaria Chamomilla L.)
Substance Name:
Matricaria Recutita
Usage Information:
Put 2 drops to each eye as needed.
11-Digit NDC Billing Format:
57619040001
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):
  • MATRICARIA RECUTITA 3 [hp_X]/mL
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date:
    04-12-2010
    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 57619-400-01?

    The NDC Packaged Code 57619-400-01 is assigned to a package of 1 bottle, plastic in 1 package / 15 ml in 1 bottle, plastic of Manzanilla Sophia, 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 57619-400 included in the NDC Directory?

    Yes, Manzanilla Sophia with product code 57619-400 is active and included in the NDC Directory. The product was first marketed by Laboratorios Sophia, S.a. De C.v. on April 12, 2010 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 57619-400-01?

    The 11-digit format is 57619040001. 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
    5-3-257619-400-015-4-257619-0400-01