Naproxen Sodium
NDC Package 59428-784-20

11-digit billing NDC: 59428078420
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Naproxen Sodium is do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour periodchildren under 12 years: ask a doctor. Marketed by Productos Zapotol Corp., this product is identified by NDC 59428-784 and is authorized under FDA application ANDA208363.

Identification & Billing

NDC Package Code
59428-784-20
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Product Code
59428-784
11-Digit Billing Format
59428078420

Clinical Specifications

Proprietary Name
Naproxen Sodium
Dosage Form
-
Usage Information
Do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour periodchildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Productos Zapotol Corp.
FDA Application #
ANDA208363
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2024
End Marketing Date
09-01-2026
Listing Expiration
09-01-2026
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59428-784-20 identifies a specific commercial package of 1 bottle, plastic in 1 box / 20 capsule, liquid filled in 1 bottle, plastic of Naproxen Sodium, labeled by Productos Zapotol Corp.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Productos Zapotol Corp. on April 30, 2024. The current certification is valid through September 01, 2026.

How is this Productos Zapotol Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59428078420. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59428-784-20
11-Digit CMS (5-4-2)
59428-0784-20

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.