Diphenhydramine Hydrochloride
NDC Package 0904-5306-80

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.

Diphenhydramine Hydrochloride is 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. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-5306 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0904-5306-80
Package Description
1000 CAPSULE in 1 BOTTLE
Product Code
0904-5306
11-Digit Billing Format
00904530680
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Major Pharmaceuticals
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-02-2009
End Marketing Date
07-31-2025
Listing Expiration
07-31-2025
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 (0904-5306). Click a package code to view its specific billing and regulatory data.

0904-5306-24
2 BLISTER PACK in 1 CARTON / 12 CAPSULE in 1 BLISTER PACK
0904-5306-60
100 CAPSULE in 1 BOTTLE
0904-5306-61
10 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK

* 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 0904-5306-80 identifies a specific commercial package of 1000 capsule in 1 bottle of Diphenhydramine Hydrochloride, labeled by Major 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 Major Pharmaceuticals on January 02, 2009. The current certification is valid through July 31, 2025.

How is this Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904530680. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 total billable units per package. 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 (4-4-2)
0904-5306-80
11-Digit CMS (5-4-2)
00904-5306-80

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