NDC Package 85509-1202-3 Naproxen And Esomeprazole Magnesium

Tablet, Delayed Release Oral - View Billable Units, 11-Digit Format, RxNorm

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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:

85509-1202-3

Package Description:

30 TABLET, DELAYED RELEASE in 1 BOTTLE

Product Code:

85509-1202

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:

85509120203

Product Type:

Human Prescription Drug

Labeler Name:

Phoenix Rx Llc

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):

Pharmacologic Class(es):

Sample Package:

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:

12-31-2026

Exclude Flag:

Code Structure:

85509 - Phoenix Rx Llc
- 85509-1202 - Naproxen And Esomeprazole Magnesium
  - 85509-1202-3 - 30 TABLET, DELAYED RELEASE in 1 BOTTLE

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 Code	Package Description
85509-1202-6	60 TABLET, DELAYED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 85509-1202-3?

The NDC Packaged Code 85509-1202-3 is assigned to a package of 30 tablet, delayed release in 1 bottle of Naproxen And Esomeprazole Magnesium, a human prescription drug labeled by Phoenix Rx Llc. The product's dosage form is tablet, delayed release and is administered via oral form.

Is NDC 85509-1202 included in the NDC Directory?

Yes, Naproxen And Esomeprazole Magnesium with product code 85509-1202 is active and included in the NDC Directory. The product was first marketed by Phoenix Rx Llc on October 06, 2022 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85509-1202-3?

The 11-digit format is 85509120203. 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 5-4-1 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	85509-1202-3	5-4-2	85509-1202-03

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