Acetaminophen Tablet, Film Coated, Extended Release
NDC Package 53329-643-29

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Acetaminophen tablets is a medication used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-643 and is authorized under FDA application ANDA076200.

Identification & Billing

NDC Package Code
53329-643-29
Package Description
50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
53329-643
11-Digit Billing Format
53329064329
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetaminophen
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 650 mg/1
Usage Information
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
ANDA076200
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2002
End Marketing Date
12-31-2026
Exclude Flag
N
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 53329-643-29 identifies a specific commercial package of 50 tablet, film coated, extended release in 1 bottle of Acetaminophen, a human over the counter drug labeled by Medline Industries, Lp. This tablet, film coated, extended release is formulated for oral use and contains acetaminophen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Medline Industries, Lp on April 30, 2002.

What are the primary indications for this medication?

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329064329. 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)
53329-643-29
11-Digit CMS (5-4-2)
53329-0643-29

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