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  5. NDC Package Code: 0054-3194-46 Diphenoxylate Hydrochloride And Atropine Sulfate

NDC Package 0054-3194-46 Diphenoxylate Hydrochloride And Atropine Sulfate

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0054-3194-46
Package Description:
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code:
0054-3194
Proprietary Name:
Diphenoxylate Hydrochloride And Atropine Sulfate
Non-Proprietary Name:
Diphenoxylate Hydrochloride And Atropine Sulfate
Substance Name:
Atropine Sulfate; Diphenoxylate Hydrochloride
Usage Information:
Diphenoxylate hydrochloride and atropine sulfate is effective as adjunctive therapy in the management of diarrhea.
11-Digit NDC Billing Format:
00054319446
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1190568 - atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1190568 - atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1190568 - atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ATROPINE SULFATE .025 mg/5mL
  • DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/5mL
    • Pharmacologic Class(es):
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Antidiarrheal - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule V (CV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA087708
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-03-1982
    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.

    Frequently Asked Questions

    What is NDC 0054-3194-46?

    The NDC Packaged Code 0054-3194-46 is assigned to a package of 1 bottle in 1 carton / 60 ml in 1 bottle of Diphenoxylate Hydrochloride And Atropine Sulfate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 0054-3194 included in the NDC Directory?

    Yes, Diphenoxylate Hydrochloride And Atropine Sulfate with product code 0054-3194 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on May 03, 1982 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 NDC billing unit for package 0054-3194-46?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0054-3194-46?

    The 11-digit format is 00054319446. 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
    4-4-20054-3194-465-4-200054-3194-46