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  5. NDC Package Code: 61314-016-01 Proparacaine Hydrochloride

NDC Package 61314-016-01 Proparacaine Hydrochloride

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:
61314-016-01
Package Description:
1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE
Product Code:
61314-016
Proprietary Name:
Proparacaine Hydrochloride
Non-Proprietary Name:
Proparacaine Hydrochloride
Substance Name:
Proparacaine Hydrochloride
Usage Information:
Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
11-Digit NDC Billing Format:
61314001601
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1191013 - proparacaine HCl 0.5 % Ophthalmic Solution
  • RxCUI: 1191013 - proparacaine hydrochloride 5 MG/ML Ophthalmic Solution
  • RxCUI: 1191013 - proparacaine hydrochloride 0.5 % Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc.
    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):
  • PROPARACAINE HYDROCHLORIDE 5 mg/mL
    • Pharmacologic Class(es):
  • Local Anesthesia - [PE] (Physiologic Effect)
  • Local Anesthetic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA080027
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-05-2000
    Listing Expiration Date:
    12-31-2024
    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 61314-016-01?

    The NDC Packaged Code 61314-016-01 is assigned to a package of 1 bottle in 1 carton / 15 ml in 1 bottle of Proparacaine Hydrochloride, a human prescription drug labeled by Sandoz Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 61314-016 included in the NDC Directory?

    Yes, Proparacaine Hydrochloride with product code 61314-016 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc. on June 05, 2000 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 61314-016-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 61314-016-01?

    The 11-digit format is 61314001601. 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
    5-3-261314-016-015-4-261314-0016-01