Diphenhydramine Hydrochloride Injection
NDC Package 42571-511-56

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 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.AntihistaminicFor amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.Motion sicknessFor active treatment of motion sickness. AntiparkinsonismFor use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combinations with centrally acting anticholinergic agents. This formulation utilizes a injection delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-511 and is authorized under FDA application ANDA219845.

Identification & Billing

NDC Package Code
42571-511-56
Package Description
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code
42571-511
11-Digit Billing Format
42571051156
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 diphenhydramine hydrochloride in the oral form is impractical.AntihistaminicFor amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.Motion sicknessFor active treatment of motion sickness. AntiparkinsonismFor use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combinations with centrally acting anticholinergic agents.

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA219845
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2025
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 42571-511-56 identifies a specific commercial package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass of Diphenhydramine Hydrochloride, a human prescription drug labeled by Micro Labs Limited. 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 Micro Labs Limited on November 01, 2025. The current certification is valid through December 31, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571051156. 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)
42571-511-56
11-Digit CMS (5-4-2)
42571-0511-56

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