Diphenhydramine Hydrochloride Tablet
NDC Package 76457-002-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Diphenhydramine Hydrochloride tablets is take every 4 to 6 hoursdo not take more than 6 does in 24 hoursAdult and children 12 years of age and over - 1 to 2 tabletChildren 6 to 12 years of age - 1 tabletChildren 6 years of age - do not use this product in children under 6 years. This formulation utilizes a tablet delivery system. Marketed by Simpex Pharma Pvt. Ltd, this product is identified by NDC 76457-002 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76457-002-00
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
76457-002
11-Digit Billing Format
76457000200
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Take every 4 to 6 hoursdo not take more than 6 does in 24 hoursAdult and children 12 years of age and over - 1 to 2 tabletChildren 6 to 12 years of age - 1 tabletChildren 6 years of age - do not use this product in children under 6 years

Regulatory & Marketing

Labeler Name
Simpex Pharma Pvt. Ltd
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-09-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 76457-002-00 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Simpex Pharma Pvt. Ltd. This tablet is formulated for oral use and contains diphenhydramine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Simpex Pharma Pvt. Ltd on February 09, 2018. The current certification is valid through December 31, 2026.

How is this Simpex Pharma Pvt. Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76457000200. 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)
76457-002-00
11-Digit CMS (5-4-2)
76457-0002-00

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