NDC Package 0904-5306-80 Diphenhydramine Hydrochloride

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

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:
0904-5306-80
Package Description:
1000 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Diphenhydramine Hydrochloride
Non-Proprietary Name:
Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Take every 4-6 hoursDo not take more than 6 doses in 24 hours25 MG adults and children 12 years of age and over1 to 2 capsuleschildren 6 years to under 12 years of age1 capsulechildren under 6 years of agedo not use this product in children under 6 years of age50 MG adults and children 12 years of age and over1 capsulechildren 6 years to under 12 years of ageAsk a doctor, the proper dosage strength is not available in this package****Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.
11-Digit NDC Billing Format:
00904530680
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1000 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1020477 - diphenhydrAMINE HCl 50 MG Oral Capsule
  • RxCUI: 1020477 - diphenhydramine hydrochloride 50 MG Oral Capsule
  • RxCUI: 1020477 - diphenhydramine HCl 50 MG Oral Capsule
  • RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
  • RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Major Pharmaceuticals
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    01-02-2009
    Listing Expiration Date:
    12-31-2024
    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
    0904-5306-242 BLISTER PACK in 1 CARTON / 12 CAPSULE in 1 BLISTER PACK
    0904-5306-60100 CAPSULE in 1 BOTTLE
    0904-5306-6110 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0904-5306-80?

    The NDC Packaged Code 0904-5306-80 is assigned to a package of 1000 capsule in 1 bottle of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Major Pharmaceuticals. The product's dosage form is capsule and is administered via oral form.

    Is NDC 0904-5306 included in the NDC Directory?

    Yes, Diphenhydramine Hydrochloride with product code 0904-5306 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on January 02, 2009 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 NDC billing unit for package 0904-5306-80?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1000.

    What is the 11-digit format for NDC 0904-5306-80?

    The 11-digit format is 00904530680. 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 4-4-2 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
    4-4-20904-5306-805-4-200904-5306-80