Diphenhydramine Hydrochloride Injection, Solution
NDC Package 84549-101-25

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 in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical. This formulation utilizes a injection, solution delivery system. Marketed by Propharma Distribution, this product is identified by NDC 84549-101 and is authorized under FDA application ANDA205723.

Identification & Billing

NDC Package Code
84549-101-25
Package Description
1 mL in 1 VIAL, SINGLE-DOSE
Product Code
84549-101
11-Digit Billing Format
84549010125
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
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 in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical.

Regulatory & Marketing

Labeler Name
Propharma Distribution
Product Type
Human Prescription Drug
FDA Application #
ANDA205723
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2019
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 84549-101-25 identifies a specific commercial package of 1 ml in 1 vial, single-dose of Diphenhydramine Hydrochloride, a human prescription drug labeled by Propharma Distribution. This injection, solution 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 Propharma Distribution on May 01, 2019. The current certification is valid through December 31, 2026.

How is this Propharma Distribution product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84549010125. 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)
84549-101-25
11-Digit CMS (5-4-2)
84549-0101-25

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