NDC Package 0573-1378-06 Preparation H

Phenylephrine Hydrochloride Suppository Rectal - View Billable Units, 11-Digit Format, RxNorm

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:
0573-1378-06
Package Description:
24 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK
Product Code:
Proprietary Name:
Preparation H
Non-Proprietary Name:
Phenylephrine Hydrochloride
Substance Name:
Phenylephrine Hydrochloride
Usage Information:
•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 the 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 the suppository•remove exposed suppository from the wrapper•insert one 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: consult a doctor
11-Digit NDC Billing Format:
00573137806
NDC to RxNorm Crosswalk:
  • RxCUI: 312398 - phenylephrine HCl 0.25 % Rectal Suppository
  • RxCUI: 312398 - phenylephrine 0.0025 MG/MG Rectal Suppository
  • RxCUI: 312398 - phenylephrine (as phenylephrine HCl) 0.25 % Rectal Suppository
  • RxCUI: 312398 - phenylephrine 0.25 % Rectal Suppository
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Haleon Us Holdings 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.
  • Sample Package:
    No
    FDA Application Number:
    M015
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    12-16-2022
    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
    0573-1378-0048 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK
    0573-1378-0112 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0573-1378-06?

    The NDC Packaged Code 0573-1378-06 is assigned to a package of 24 blister pack in 1 carton / 1 suppository in 1 blister pack of Preparation H, a human over the counter drug labeled by Haleon Us Holdings Llc. The product's dosage form is suppository and is administered via rectal form.

    Is NDC 0573-1378 included in the NDC Directory?

    Yes, Preparation H with product code 0573-1378 is active and included in the NDC Directory. The product was first marketed by Haleon Us Holdings Llc on December 16, 2022 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 0573-1378-06?

    The 11-digit format is 00573137806. 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 4-4-2 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
    4-4-20573-1378-065-4-200573-1378-06