Diphenhydramine Hydrochloride Injection
NDC Package 0641-0376-25

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

Package Information

Diphenhydramine Hydrochloride injection is diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical:. This formulation utilizes a injection delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0641-0376 and is authorized under FDA application ANDA080817.

Identification & Billing

NDC Package Code
0641-0376-25
Package Description
25 VIAL in 1 PACKAGE / 1 mL in 1 VIAL (0641-0376-21)
Product Code
0641-0376
11-Digit Billing Format
00641037625
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL
Pharmacologic Class
Usage Information
Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical:

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA080817
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-27-1972
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 0641-0376-25 identifies a specific commercial package of 25 vial in 1 package / 1 ml in 1 vial (0641-0376-21) of Diphenhydramine Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection is formulated for intramuscular; intravenous 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 Hikma Pharmaceuticals Usa Inc. on November 27, 1972. The current certification is valid through December 31, 2026.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00641037625. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0641-0376-25
11-Digit CMS (5-4-2)
00641-0376-25

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