Promethazine Hydrochloride Injection, Solution
NDC Package 39822-5525-3

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

Package Information

Promethazine Hydrochloride injection is indicated for the following conditions:1. This formulation utilizes a injection, solution delivery system. Marketed by Xgen Pharmaceuticals Djb, Inc., this product is identified by NDC 39822-5525 and is authorized under FDA application ANDA040737.

Identification & Billing

NDC Package Code
39822-5525-3
Package Description
25 AMPULE in 1 CARTON / 1 mL in 1 AMPULE (39822-5525-2)
Product Code
39822-5525
11-Digit Billing Format
39822552503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Promethazine Hydrochloride
Non-Proprietary Name
Promethazine Hydrochloride
Substance Name
Promethazine 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)
PROMETHAZINE HYDROCHLORIDE 25 mg/mL
Pharmacologic Class
Usage Information
Promethazine hydrochloride injection is indicated for the following conditions:1. Amelioration of allergic reactions to blood or plasma.2. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.3. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.4. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.5. Active treatment of motion sickness.6. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.7. As an adjunct to analgesics for the control of postoperative pain.8. Preoperative, postoperative, and obstetric (during labor) sedation.9. Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

Regulatory & Marketing

Labeler Name
Xgen Pharmaceuticals Djb, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040737
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-30-2015
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2550
Source: ASP
Promethazine hcl injection
HCPCS Dosage 50 MG
Units / Pkg 13

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 39822-5525-3 identifies a specific commercial package of 25 ampule in 1 carton / 1 ml in 1 ampule (39822-5525-2) of Promethazine Hydrochloride, a human prescription drug labeled by Xgen Pharmaceuticals Djb, Inc.. This injection, solution is formulated for intramuscular; intravenous use and contains promethazine 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 Xgen Pharmaceuticals Djb, Inc. on January 30, 2015. The current certification is valid through December 31, 2026.

How is this Xgen Pharmaceuticals Djb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 39822552503. 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 (5-4-1)
39822-5525-3
11-Digit CMS (5-4-2)
39822-5525-03

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