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  5. NDC Package Code: 47335-317-94 Xelpros

NDC Package 47335-317-94 Xelpros

Latanoprost Solution/ Drops Ophthalmic; Topical - 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:
47335-317-94
Package Description:
3 BOTTLE, DROPPER in 1 BOX / 2.5 mL in 1 BOTTLE, DROPPER
Product Code:
47335-317
Proprietary Name:
Xelpros
Non-Proprietary Name:
Latanoprost
Substance Name:
Latanoprost
Usage Information:
Latanoprost is used to treat high pressure inside the eye due to glaucoma (open angle type) or other eye diseases (e.g., ocular hypertension). It is similar to a natural chemical in the body (prostaglandin) and works by regulating the flow of fluid within the eye which results in lower pressure. Lowering high pressure inside the eye helps to prevent blindness.
11-Digit NDC Billing Format:
47335031794
NDC to RxNorm Crosswalk:
  • RxCUI: 2056743 - latanoprost 0.005 % Ophthalmic Emulsion
  • RxCUI: 2056743 - latanoprost 0.05 MG/ML Ophthalmic Suspension
  • RxCUI: 2056743 - latanoprost 0.05 MG/ML Ophthalmic Emulsion
  • RxCUI: 2056748 - Xelprox 0.005 % Ophthalmic Emulsion
  • RxCUI: 2056748 - latanoprost 0.05 MG/ML Ophthalmic Suspension [Xelpros]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, 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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • LATANOPROST .05 mg/mL
    • Pharmacologic Class(es):
  • Prostaglandin Analog - [EPC] (Established Pharmacologic Class)
  • Prostaglandins - [CS]
    • Sample Package:
    Yes
    FDA Application Number:
    NDA206185
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-12-2018
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    47335-317-901 BOTTLE, DROPPER in 1 BOX / 2.5 mL in 1 BOTTLE, DROPPER
    47335-317-923 BOTTLE, DROPPER in 1 BOX / 2.5 mL in 1 BOTTLE, DROPPER
    47335-317-981 BOTTLE, DROPPER in 1 BOX / 2.5 mL in 1 BOTTLE, DROPPER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 47335-317-94?

    The NDC Packaged Code 47335-317-94 is assigned to a package of 3 bottle, dropper in 1 box / 2.5 ml in 1 bottle, dropper of Xelpros, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic; topical form.

    Is NDC 47335-317 included in the NDC Directory?

    Yes, Xelpros with product code 47335-317 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on September 12, 2018 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 11-digit format for NDC 47335-317-94?

    The 11-digit format is 47335031794. 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
    5-3-247335-317-945-4-247335-0317-94