Medline
NDC Package 53329-197-29

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Medline is ■ do not take more than directed (see overdose warning)adults■ take 2 caplets every 8 hours with water■ swallow whole; do not crush, chew, split or dissolve■ do not take more than 6 caplets in 24 hours■ do not use for more than 10 days unless directed by a doctorunder 18 years of age■ ask a doctor. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-197 and is authorized under FDA application ANDA211544.

Identification & Billing

NDC Package Code
53329-197-29
Package Description
50 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
53329-197
11-Digit Billing Format
53329019729

Clinical Specifications

Proprietary Name
Medline
Dosage Form
-
Usage Information
■ do not take more than directed (see overdose warning)adults■ take 2 caplets every 8 hours with water■ swallow whole; do not crush, chew, split or dissolve■ do not take more than 6 caplets in 24 hours■ do not use for more than 10 days unless directed by a doctorunder 18 years of age■ ask a doctor

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
FDA Application #
ANDA211544
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2024
End Marketing Date
04-30-2026
Listing Expiration
04-30-2026
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 53329-197-29 identifies a specific commercial package of 50 tablet, extended release in 1 bottle of Medline, labeled by Medline Industries, Lp. 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 Medline Industries, Lp on July 01, 2024. The current certification is valid through April 30, 2026.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329019729. 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)
53329-197-29
11-Digit CMS (5-4-2)
53329-0197-29

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