Promethazine Hydrochloride Injection
NDC Package 0404-9941-01

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

Package Information

Promethazine Hydrochloride injection is indicated for the following conditions: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.For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.Active treatment of motion sickness.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.As an adjunct to analgesics for the control of postoperative pain.Preoperative, postoperative, and obstetric (during labor) sedation.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. This formulation utilizes a injection delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9941 and is authorized under FDA application ANDA083312.

Identification & Billing

NDC Package Code
0404-9941-01
Package Description
1 AMPULE in 1 BAG / 1 mL in 1 AMPULE
Product Code
0404-9941
11-Digit Billing Format
00404994101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Promethazine Hydrochloride
Non-Proprietary Name
Promethazine Hydrochloride
Substance Name
Promethazine 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)
PROMETHAZINE HYDROCHLORIDE 25 mg/mL
Pharmacologic Class
Usage Information
Promethazine hydrochloride injection is indicated for the following conditions: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.For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.Active treatment of motion sickness.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.As an adjunct to analgesics for the control of postoperative pain.Preoperative, postoperative, and obstetric (during labor) sedation.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
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA083312
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-17-2022
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 0404-9941-01 identifies a specific commercial package of 1 ampule in 1 bag / 1 ml in 1 ampule of Promethazine Hydrochloride, a human prescription drug labeled by Henry Schein, Inc.. This injection 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 Henry Schein, Inc. on January 17, 2022. The current certification is valid through December 31, 2026.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404994101. 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)
0404-9941-01
11-Digit CMS (5-4-2)
00404-9941-01

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