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  5. NDC Package Code: 75826-107-00 Diphenoxylate Hydrochloride And Atropine Sulfate

NDC Package 75826-107-00 Diphenoxylate Hydrochloride And Atropine Sulfate

Tablet 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:
75826-107-00
Package Description:
1000 TABLET in 1 BOTTLE, PLASTIC
Product Code:
75826-107
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 indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
11-Digit NDC Billing Format:
75826010700
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1000 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1190572 - diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet
  • RxCUI: 1190572 - atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Winder Laboratories Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ATROPINE SULFATE .025 mg/1
  • DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1
    • 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:
    ANDA211362
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-30-2022
    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
    75826-107-03100 TABLET in 1 BOTTLE, PLASTIC
    75826-107-1110 TABLET in 1 BOTTLE, PLASTIC
    75826-107-3330 TABLET in 1 BOTTLE, PLASTIC
    75826-107-9090 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 75826-107-00?

    The NDC Packaged Code 75826-107-00 is assigned to a package of 1000 tablet in 1 bottle, plastic of Diphenoxylate Hydrochloride And Atropine Sulfate, a human prescription drug labeled by Winder Laboratories Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 75826-107 included in the NDC Directory?

    Yes, Diphenoxylate Hydrochloride And Atropine Sulfate with product code 75826-107 is active and included in the NDC Directory. The product was first marketed by Winder Laboratories Llc on April 30, 2022 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 75826-107-00?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1000.

    What is the 11-digit format for NDC 75826-107-00?

    The 11-digit format is 75826010700. 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
    5-3-275826-107-005-4-275826-0107-00