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  5. NDC Package Code: 82568-0016-8 Diphenhydramine Hcl 12.5 Mg Per 5 Ml

NDC Package 82568-0016-8 Diphenhydramine Hcl 12.5 Mg Per 5 Ml

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
82568-0016-8
Package Description:
236 mL in 1 BOTTLE
Product Code:
82568-0016
Proprietary Name:
Diphenhydramine Hcl 12.5 Mg Per 5 Ml
Non-Proprietary Name:
Diphenhydramine Hcl 12.5 Mg Per 5 Ml
Substance Name:
Diphenhydramine
Usage Information:
Directionsdo not take more than 6 doses in any 24 hourstake every 4 to 6 hours, or as directed by a doctormL = milliliterkeep dosing cup with productfind the right dose on the chart below Age (yr) Dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years Do not use unless directed by a doctor children under 2 years Do not use
11-Digit NDC Billing Format:
82568001608
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
236 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1049906 - diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine HCl 12.5 MG per 5 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution
Product Type:
Human Otc Drug
Labeler Name:
Aarna Usa Inc.
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
DIPHENHYDRAMINE 12.5 mg/5mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
M012
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
04-14-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 CodePackage Description
82568-0016-4118 mL in 1 BOTTLE
82568-0016-6473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 82568-0016-8?

The NDC Packaged Code 82568-0016-8 is assigned to a package of 236 ml in 1 bottle of Diphenhydramine Hcl 12.5 Mg Per 5 Ml, a human over the counter drug labeled by Aarna Usa Inc.. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 236 billable units per package.

Is NDC 82568-0016 included in the NDC Directory?

Yes, Diphenhydramine Hcl 12.5 Mg Per 5 Ml with product code 82568-0016 is active and included in the NDC Directory. The product was first marketed by Aarna Usa Inc. on April 14, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 82568-0016-8?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 236.

What is the 11-digit format for NDC 82568-0016-8?

The 11-digit format is 82568001608. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-182568-0016-85-4-282568-0016-08