Promethazine Hydrochloride Syrup
NDC Package 0116-4023-16

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 syrups is promethazine is useful for:Perennial and seasonal allergic rhinitis. This formulation utilizes a syrup delivery system. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-4023 and is authorized under FDA application ANDA087953.

Identification & Billing

NDC Package Code
0116-4023-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0116-4023
11-Digit Billing Format
00116402316
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Promethazine Hydrochloride
Non-Proprietary Name
Promethazine Hydrochloride
Substance Name
Promethazine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA087953
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-07-2025
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.

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.

Q0169
Source: PDAC
PROMETHAZINE 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 REGIMEN
HCPCS Dosage 12.5 MG
Units / Pkg

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 0116-4023-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride, a human prescription drug labeled by Xttrium Laboratories, Inc.. This syrup is formulated for oral 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 Xttrium Laboratories, Inc. on April 07, 2025. The current certification is valid through December 31, 2026.

How is this Xttrium Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116402316. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 total billable units per package. 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)
0116-4023-16
11-Digit CMS (5-4-2)
00116-4023-16

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