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  5. NDC Package Code: 27241-203-60 Naproxen And Esomeprazole Magnesium

NDC Package 27241-203-60 Naproxen And Esomeprazole Magnesium

Tablet, Delayed Release 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:
27241-203-60
Package Description:
60 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
27241-203
Proprietary Name:
Naproxen And Esomeprazole Magnesium
Non-Proprietary Name:
Naproxen And Esomeprazole Magnesium
Substance Name:
Esomeprazole Magnesium; Naproxen
Usage Information:
Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers.The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients.The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers.Limitations of Use:Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium.Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months [see Use in Specific Populations (8.4), Clinical Studies (14)].
11-Digit NDC Billing Format:
27241020360
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 994005 - naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet
  • RxCUI: 994005 - esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet
  • RxCUI: 994005 - esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet
  • RxCUI: 994008 - naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet
  • RxCUI: 994008 - esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ajanta Pharma Usa Inc.
    Dosage Form:
    Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ESOMEPRAZOLE MAGNESIUM 20 mg/1
  • NAPROXEN 500 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213699
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-06-2022
    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.

    Frequently Asked Questions

    What is NDC 27241-203-60?

    The NDC Packaged Code 27241-203-60 is assigned to a package of 60 tablet, delayed release in 1 bottle of Naproxen And Esomeprazole Magnesium, a human prescription drug labeled by Ajanta Pharma Usa Inc.. The product's dosage form is tablet, delayed release and is administered via oral form.

    Is NDC 27241-203 included in the NDC Directory?

    Yes, Naproxen And Esomeprazole Magnesium with product code 27241-203 is active and included in the NDC Directory. The product was first marketed by Ajanta Pharma Usa Inc. on October 06, 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 27241-203-60?

    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 60.

    What is the 11-digit format for NDC 27241-203-60?

    The 11-digit format is 27241020360. 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
    5-3-227241-203-605-4-227241-0203-60