Diphenhydramine Hydrochloirde Tablets Tablet
NDC Package 57631-003-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Diphenhydramine Hydrochloirde Tablets tablets is a drug for further processing. This formulation utilizes a tablet delivery system. Marketed by Invatech Pharma Solutions Llc, this product is identified by NDC 57631-003.

Identification & Billing

NDC Package Code
57631-003-00
Package Description
100000 TABLET in 1 DRUM
Product Code
57631-003
11-Digit Billing Format
57631000300

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloirde Tablets
Non-Proprietary Name
Diphenhydramine Hydrochloirde Tablets
Substance Name
Diphenhydramine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
DIPHENHYDRAMINE 25 mg/1

Regulatory & Marketing

Labeler Name
Invatech Pharma Solutions Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-26-2013
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 57631-003-00 identifies a specific commercial package of 100000 tablet in 1 drum of Diphenhydramine Hydrochloirde Tablets (UNFINISHED drug), drug for further processing labeled by Invatech Pharma Solutions Llc. This tablet is formulated for use and contains diphenhydramine 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 Invatech Pharma Solutions Llc on September 26, 2013. The current certification is valid through December 31, 2027.

How is this Invatech Pharma Solutions Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57631000300. 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)
57631-003-00
11-Digit CMS (5-4-2)
57631-0003-00

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