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  5. NDC Package Code: 43749-430-12 Avedana Hemorrhoidal

NDC Package 43749-430-12 Avedana Hemorrhoidal

Hemorrhoidal Rectal Suppositories Suppository Rectal - 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:
43749-430-12
Package Description:
2 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK (43749-430-13)
Product Code:
43749-430
Proprietary Name:
Avedana Hemorrhoidal
Non-Proprietary Name:
Hemorrhoidal Rectal Suppositories
Substance Name:
Cocoa Butter; Phenylephrine Hydrochloride
Usage Information:
Directions: Adults-when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.-detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:-hold suppository with rounded end up-as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"-slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose from wrapper-insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement-children under 12 years of age: ask a doctor
11-Digit NDC Billing Format:
43749043012
NDC to RxNorm Crosswalk:
  • RxCUI: 1438497 - cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository
  • RxCUI: 1438497 - cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Unipack Llc
    Dosage Form:
    Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
    Administration Route(s):
  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.
    • Active Ingredient(s):
  • COCOA BUTTER 2211 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 6.25 g/1
  • COCOA BUTTER 2211 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M015
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    09-18-2014
    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
    43749-430-244 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK (43749-430-25)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43749-430-12?

    The NDC Packaged Code 43749-430-12 is assigned to a package of 2 blister pack in 1 carton / 6 suppository in 1 blister pack (43749-430-13) of Avedana Hemorrhoidal, a human over the counter drug labeled by Unipack Llc. The product's dosage form is suppository and is administered via rectal form.

    Is NDC 43749-430 included in the NDC Directory?

    Yes, Avedana Hemorrhoidal with product code 43749-430 is active and included in the NDC Directory. The product was first marketed by Unipack Llc on September 18, 2014 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 43749-430-12?

    The 11-digit format is 43749043012. 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
    5-3-243749-430-125-4-243749-0430-12