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  5. NDC Package Code: 53489-376-03 Trimethobenzamide Hydrochloride

NDC Package 53489-376-03 Trimethobenzamide Hydrochloride

Capsule Oral - 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:
53489-376-03
Package Description:
250 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
53489-376
Proprietary Name:
Trimethobenzamide Hydrochloride
Non-Proprietary Name:
Trimethobenzamide Hydrochloride
Substance Name:
Trimethobenzamide Hydrochloride
Usage Information:
Trimethobenzamide hydrochloride capsules are indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.Limitation of Use:Trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects, and the risk of exacerbation of the underlying disease in pediatric patients with Reye’s syndrome or other hepatic impairment.
11-Digit NDC Billing Format:
53489037603
NDC to RxNorm Crosswalk:
  • RxCUI: 860771 - trimethobenzamide HCl 300 MG Oral Capsule
  • RxCUI: 860771 - trimethobenzamide hydrochloride 300 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1
    • Pharmacologic Class(es):
  • Antiemetic - [EPC] (Established Pharmacologic Class)
  • Emesis Suppression - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076570
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-28-2003
    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
    53489-376-01100 CAPSULE in 1 BOTTLE, PLASTIC
    53489-376-05500 CAPSULE in 1 BOTTLE, PLASTIC
    53489-376-0660 CAPSULE in 1 BOTTLE, PLASTIC
    53489-376-0730 CAPSULE in 1 BOTTLE, PLASTIC
    53489-376-101000 CAPSULE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53489-376-03?

    The NDC Packaged Code 53489-376-03 is assigned to a package of 250 capsule in 1 bottle, plastic of Trimethobenzamide Hydrochloride, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 53489-376 included in the NDC Directory?

    Yes, Trimethobenzamide Hydrochloride with product code 53489-376 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on August 28, 2003 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 53489-376-03?

    The 11-digit format is 53489037603. 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
    5-3-253489-376-035-4-253489-0376-03