Arthritis Pain Tablet, Extended Release
NDC Package 68196-034-02

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

Package Information

Arthritis Pain (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, extended release delivery system. Marketed by Sam's West Inc, this product is identified by NDC 68196-034 and is authorized under FDA application ANDA215486.

Identification & Billing

NDC Package Code
68196-034-02
Package Description
200 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68196-034
11-Digit Billing Format
68196003402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Arthritis Pain
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
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
Sam's West Inc
Product Type
Human Otc Drug
FDA Application #
ANDA215486
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-20-2025
Listing Expiration
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 68196-034-02 identifies a specific commercial package of 200 tablet, extended release in 1 bottle of Arthritis Pain, a human over the counter drug labeled by Sam's West Inc. This tablet, 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 Sam's West Inc on August 20, 2025. The current certification is valid through December 31, 2026.

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 Sam's West Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68196003402. 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)
68196-034-02
11-Digit CMS (5-4-2)
68196-0034-02

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