NDC Package 70748-215-07 Naproxen And Esomeprazole Magnesium

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
70748-215-07
Package Description:
60 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Naproxen And Esomeprazole Magnesium
Usage Information:
Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, are 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 tablets 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 tablets is indicated to decrease the risk of developing naproxen-associated gastric ulcers.Limitations of Use:  Do not substitute naproxen and esomeprazole magnesium delayed-release tablet with the single-ingredient products of naproxen and esomeprazole magnesium.  Naproxen and esomeprazole magnesium delayed-release tablet is 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:
70748021507
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
Labeler Name:
Lupin Pharmaceuticals, Inc.
Sample Package:
No
FDA Application Number:
NDA022511
Marketing Category:
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date:
03-04-2020
End Marketing Date:
09-30-2024
Listing Expiration Date:
09-30-2024
Exclude Flag:
D
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.

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Frequently Asked Questions

What is NDC 70748-215-07?

The NDC Packaged Code 70748-215-07 is assigned to a package of 60 tablet, delayed release in 1 bottle of Naproxen And Esomeprazole Magnesium, labeled by Lupin Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 70748-215 included in the NDC Directory?

No, Naproxen And Esomeprazole Magnesium with product code 70748-215 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Lupin Pharmaceuticals, Inc. on March 04, 2020 and its listing in the NDC Directory is set to expire on September 30, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 70748-215-07?

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 70748-215-07?

The 11-digit format is 70748021507. 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
5-3-270748-215-075-4-270748-0215-07