Xl-3 Xtreme Liquid
NDC Package 76281-307-25

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

Package Information

Xl-3 Xtreme (acetaminophen, dextromethorphan hbr, doxylamine succinate) liquids is • take only as recommended-see Overdose warning• Use dose cup or tablespoon (TBSP) • do not exceed 4 doses per 24 hours • if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.adults & children 12 years and over           30 mL (2 TBSP) every 6 hourschildren 4 to under 12 years                        ask a doctorchildren under 4 years                                 do not use. This formulation utilizes a liquid delivery system. Marketed by Aptapharma Inc., this product is identified by NDC 76281-307 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76281-307-25
Package Description
177 mL in 1 BOTTLE
Product Code
76281-307
11-Digit Billing Format
76281030725
RxNorm Crosswalk
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Xl-3 Xtreme
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• take only as recommended-see Overdose warning• Use dose cup or tablespoon (TBSP) • do not exceed 4 doses per 24 hours • if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.adults & children 12 years and over           30 mL (2 TBSP) every 6 hourschildren 4 to under 12 years                        ask a doctorchildren under 4 years                                 do not use

Regulatory & Marketing

Labeler Name
Aptapharma Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2018
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 76281-307-25 identifies a specific commercial package of 177 ml in 1 bottle of Xl-3 Xtreme, a human over the counter drug labeled by Aptapharma Inc.. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate 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 Aptapharma Inc. on September 01, 2018. The current certification is valid through December 31, 2026.

How is this Aptapharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76281030725. 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 (5-3-2)
76281-307-25
11-Digit CMS (5-4-2)
76281-0307-25

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