Acetaminophen
NDC Package 51645-600-01

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

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

Acetaminophen 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. Marketed by Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals, this product is identified by NDC 51645-600 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
51645-600-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
51645-600
11-Digit Billing Format
51645060001

Clinical Specifications

Proprietary Name
Acetaminophen
Dosage Form
-
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
Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
03-30-2012
End Marketing Date
11-30-2017
Listing Expiration
11-30-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51645-600). Click a package code to view its specific billing and regulatory data.

51645-600-10
1000 TABLET 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 51645-600-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Acetaminophen, labeled by Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals. 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 Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals on March 30, 2012. The current certification is valid through November 30, 2017.

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 Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51645060001. 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)
51645-600-01
11-Digit CMS (5-4-2)
51645-0600-01

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