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  5. NDC Package Code: 0378-2350-77 Esomeprazole Magnesium

NDC Package 0378-2350-77 Esomeprazole Magnesium

Capsule, Delayed Release Pellets 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:
0378-2350-77
Package Description:
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC
Product Code:
0378-2350
Proprietary Name:
Esomeprazole Magnesium
Non-Proprietary Name:
Esomeprazole Magnesium
Substance Name:
Esomeprazole Magnesium
Usage Information:
Esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter esomeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
11-Digit NDC Billing Format:
00378235077
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 606726 - esomeprazole magnesium 20 MG Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule
  • RxCUI: 606730 - esomeprazole magnesium 40 MG Delayed Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ESOMEPRAZOLE MAGNESIUM 20 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078936
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-03-2015
    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
    0378-2350-9330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-2350-77?

    The NDC Packaged Code 0378-2350-77 is assigned to a package of 90 capsule, delayed release pellets in 1 bottle, plastic of Esomeprazole Magnesium, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is capsule, delayed release pellets and is administered via oral form.

    Is NDC 0378-2350 included in the NDC Directory?

    Yes, Esomeprazole Magnesium with product code 0378-2350 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on August 03, 2015 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 NDC billing unit for package 0378-2350-77?

    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 90.

    What is the 11-digit format for NDC 0378-2350-77?

    The 11-digit format is 00378235077. 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
    4-4-20378-2350-775-4-200378-2350-77