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  5. NDC Package Code: 0116-4023-16 Promethazine Hydrochloride

NDC Package 0116-4023-16 Promethazine Hydrochloride

Syrup Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0116-4023-16
Package Description:
473 mL in 1 BOTTLE, PLASTIC
Product Code:
0116-4023
Proprietary Name:
Promethazine Hydrochloride
Non-Proprietary Name:
Promethazine Hydrochloride
Substance Name:
Promethazine Hydrochloride
Usage Information:
Promethazine is useful for:Perennial and seasonal allergic rhinitis. Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.Preoperative, postoperative, or obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.
11-Digit NDC Billing Format:
00116402316
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Xttrium Laboratories, Inc.
Dosage Form:
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA087953
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-07-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0116-4023-16 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00116402316Q0169PROMETHAZINE HYDROCHLORIDE, 12.5 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN12.5 MG473ML

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0116-4023-16?

The NDC Packaged Code 0116-4023-16 is assigned to a package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride, a human prescription drug labeled by Xttrium Laboratories, Inc.. The product's dosage form is syrup and is administered via oral form.

Is NDC 0116-4023 included in the NDC Directory?

Yes, Promethazine Hydrochloride with product code 0116-4023 is active and included in the NDC Directory. The product was first marketed by Xttrium Laboratories, Inc. on April 07, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0116-4023-16?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

What is the 11-digit format for NDC 0116-4023-16?

The 11-digit format is 00116402316. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20116-4023-165-4-200116-4023-16