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  5. NDC Package Code: 53002-3440-2 Hydrocortisone Acetate

NDC Package 53002-3440-2 Hydrocortisone Acetate

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:
53002-3440-2
Package Description:
12 SUPPOSITORY in 1 BOX
Product Code:
53002-3440
Proprietary Name:
Hydrocortisone Acetate
Non-Proprietary Name:
Hydrocortisone Acetate
Substance Name:
Hydrocortisone Acetate
Usage Information:
This medication is used to treat hemorrhoids and itching/swelling in the rectum and anus. It is also used with other medications to treat certain intestinal problems (such as ulcerative colitis of the rectum and other rectal/anal inflammatory conditions). Hydrocortisone suppositories help to relieve rectal pain, itching, bloody diarrhea, and bleeding by reducing swelling (inflammation) directly in the rectum and anus. Hydrocortisone belongs to a class of drugs called corticosteroids.
11-Digit NDC Billing Format:
53002344002
NDC to RxNorm Crosswalk:
  • RxCUI: 1291082 - hydrocortisone acetate 25 MG Rectal Suppository
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    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.
    • Active Ingredient(s):
  • HYDROCORTISONE ACETATE 25 mg/1
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    05-01-2017
    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
    53002-3440-16 SUPPOSITORY in 1 BOX

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-3440-2?

    The NDC Packaged Code 53002-3440-2 is assigned to a package of 12 suppository in 1 box of Hydrocortisone Acetate, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is suppository and is administered via rectal form.

    Is NDC 53002-3440 included in the NDC Directory?

    Yes, Hydrocortisone Acetate with product code 53002-3440 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on May 01, 2017 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 53002-3440-2?

    The 11-digit format is 53002344002. 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 5-4-1 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
    5-4-153002-3440-25-4-253002-3440-02