NDC Package 71399-0160-8 Acetaminophen

Elixir Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

71399-0160-8

Package Description:

236 mL in 1 BOTTLE

Product Code:

71399-0160

Proprietary Name:

Acetaminophen

Non-Proprietary Name:

Acetaminophen

Substance Name:

Acetaminophen

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.

11-Digit NDC Billing Format:

71399016008

NDC to RxNorm Crosswalk:

RxCUI: 307675 - acetaminophen 160 MG in 5 mL Oral Solution

RxCUI: 307675 - acetaminophen 32 MG/ML Oral Solution

RxCUI: 307675 - acetaminophen 160 MG per 5 ML Oral Solution

RxCUI: 307675 - acetaminophen 325 MG per 10.15 ML Oral Solution

RxCUI: 307675 - acetaminophen 650 MG per 20.3 ML Oral Solution

Product Type:

Human Otc Drug

Labeler Name:

Akron Pharma Inc.

Dosage Form:

Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

ACETAMINOPHEN 160 mg/5mL

Sample Package:

FDA Application Number:

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:

05-18-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

71399 - Akron Pharma Inc.
- 71399-0160 - Acetaminophen
  - 71399-0160-8 - 236 mL in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
71399-0160-4	118 mL in 1 BOTTLE
71399-0160-6	473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 71399-0160-8?

The NDC Packaged Code 71399-0160-8 is assigned to a package of 236 ml in 1 bottle of Acetaminophen, a human over the counter drug labeled by Akron Pharma Inc.. The product's dosage form is elixir and is administered via oral form.

Is NDC 71399-0160 included in the NDC Directory?

Yes, Acetaminophen with product code 71399-0160 is active and included in the NDC Directory. The product was first marketed by Akron Pharma Inc. on May 18, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 71399-0160-8?

The 11-digit format is 71399016008. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	71399-0160-8	5-4-2	71399-0160-08

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