8 Hour Arthritis Pain Tablet, Extended Release
NDC Package 46122-629-71

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

Package Information

8 Hour 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 Amerisource Bergen, this product is identified by NDC 46122-629 and is authorized under FDA application ANDA211544.

Identification & Billing

NDC Package Code
46122-629-71
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
46122-629
11-Digit Billing Format
46122062971
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
8 Hour 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
Amerisource Bergen
Product Type
Human Otc Drug
FDA Application #
ANDA211544
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-13-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (46122-629). Click a package code to view its specific billing and regulatory data.

46122-629-62
1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
46122-629-78
1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
46122-629-81
200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 46122-629-71 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 50 tablet, extended release in 1 bottle, plastic of 8 Hour Arthritis Pain, a human over the counter drug labeled by Amerisource Bergen. 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 Amerisource Bergen on January 13, 2020. 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 Amerisource Bergen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122062971. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
46122-629-71
11-Digit CMS (5-4-2)
46122-0629-71

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