Acetaminophen
NDC Package 72091-004-01

11-digit billing NDC: 72091000401
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 inactivated by the FDA.

Acetaminophen is • do not take more than directedThis product does not contain directions or complete warnings for adult use.• find dose in chart below, if possible, use weight to dose, otherwise use age• dosage may be repeated every 4 hours as needed, or as directed by a doctor• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoonWeight (lb)Under 2424-3636-4748-5960-7172-95age (yr)Under 22-34-56-89-1011Dosage (mL)ask a doctor5 mL7.5 mL10 mL12.5 mL15 mL. Marketed by Samjan Group Inc., this product is identified by NDC 72091-004 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
72091-004-01
Package Description
237 mL in 1 BOTTLE
Product Code
72091-004
11-Digit Billing Format
72091000401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetaminophen
Dosage Form
-
Usage Information
• do not take more than directedThis product does not contain directions or complete warnings for adult use.• find dose in chart below, if possible, use weight to dose, otherwise use age• dosage may be repeated every 4 hours as needed, or as directed by a doctor• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoonWeight (lb)Under 2424-3636-4748-5960-7172-95age (yr)Under 22-34-56-89-1011Dosage (mL)ask a doctor5 mL7.5 mL10 mL12.5 mL15 mL

Regulatory & Marketing

Labeler Name
Samjan Group Inc.
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
03-17-2021
Listing Expiration
12-31-2022
Exclude Flag
I
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 72091-004-01 identifies a specific commercial package of 237 ml in 1 bottle of Acetaminophen, labeled by Samjan Group Inc.. 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 Samjan Group Inc. on March 17, 2021. The current certification is valid through December 31, 2022.

How is this Samjan Group Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72091000401. 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)
72091-004-01
11-Digit CMS (5-4-2)
72091-0004-01

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