Promethazine Hydrochloride
NDC Package 54868-4021-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Promethazine Hydrochloride is 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. . Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4021 and is authorized under FDA application ANDA040737.

Identification & Billing

NDC Package Code
54868-4021-0
Package Description
25 AMPULE in 1 CARTON / 1 mL in 1 AMPULE
Product Code
54868-4021
11-Digit Billing Format
54868402100
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Promethazine Hydrochloride
Dosage Form
-
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
Physicians Total Care, Inc.
FDA Application #
ANDA040737
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-29-2000
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-4021-0 identifies a specific commercial package of 25 ampule in 1 carton / 1 ml in 1 ampule of Promethazine Hydrochloride, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on February 29, 2000. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868402100. 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 (5-4-1)
54868-4021-0
11-Digit CMS (5-4-2)
54868-4021-00

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