Xpecto
NDC Package 76095-005-14

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.

Xpecto is shake well before usingdo not take more than 4 doses in any 24-hour periodmeasure only with dosing cup providedkeep dosing cup with product mL=milliliterthis adult product is not intended for use in children under 12 years of ageadults and children 12 years and over: 10mL every 4 hourschildren under 12 years: do not use. Marketed by Midway Importing Inc, this product is identified by NDC 76095-005 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
76095-005-14
Package Description
118 mL in 1 BOTTLE
Product Code
76095-005
11-Digit Billing Format
76095000514
RxNorm Crosswalk
  • RxCUI: 1604325 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Suspension
  • RxCUI: 1604325 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Suspension
  • RxCUI: 1604325 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Suspension
  • RxCUI: 1604325 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / phenylephrine hydrochloride 10 MG per 10 ML Oral Suspension

Clinical Specifications

Proprietary Name
Xpecto Soothing Relief
Dosage Form
-
Usage Information
Shake well before usingdo not take more than 4 doses in any 24-hour periodmeasure only with dosing cup providedkeep dosing cup with product mL=milliliterthis adult product is not intended for use in children under 12 years of ageadults and children 12 years and over: 10mL every 4 hourschildren under 12 years: do not use

Regulatory & Marketing

Labeler Name
Midway Importing Inc
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-09-2016
Listing Expiration
12-31-2022
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 76095-005-14 identifies a specific commercial package of 118 ml in 1 bottle of Xpecto Soothing Relief, labeled by Midway Importing 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 Midway Importing Inc on May 09, 2016. The current certification is valid through December 31, 2022.

How is this Midway Importing Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76095000514. 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)
76095-005-14
11-Digit CMS (5-4-2)
76095-0005-14

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