Guaifenesin Extended-release Tablet, Multilayer, Extended Release
NDC Package 68094-048-61

11-digit billing NDC: 68094004861 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Guaifenesin Extended-release (guaifenesin) tablets is use as directed per healthcare professional.do not crush, chew, or break tablettake with a full glass of waterthis product can be administered without regard for the timing of mealsadults and children 12 years of age and over: 1 or 2 tablets every 12 hours. This formulation utilizes a tablet, multilayer, extended release delivery system. Marketed by Precision Dose Inc., this product is identified by NDC 68094-048 and is authorized under FDA application ANDA078912.

Identification & Billing

NDC Package Code
68094-048-61
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59)
Product Code
68094-048
11-Digit Billing Format
68094004861
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 636522 - guaiFENesin 600 MG 12HR Extended Release Oral Tablet
  • RxCUI: 636522 - 12 HR guaifenesin 600 MG Extended Release Oral Tablet
  • RxCUI: 636522 - guaifenesin 600 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Guaifenesin Extended-release
Non-Proprietary Name
Guaifenesin
Substance Name
Guaifenesin
Dosage Form
Tablet, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GUAIFENESIN 600 mg/1
Pharmacologic Class
Usage Information
Use as directed per healthcare professional.do not crush, chew, or break tablettake with a full glass of waterthis product can be administered without regard for the timing of mealsadults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Precision Dose Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA078912
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-22-2023
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 68094-048-61 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet, multilayer, extended release in 1 blister pack (68094-048-59) of Guaifenesin Extended-release, a human over the counter drug labeled by Precision Dose Inc.. This tablet, multilayer, extended release is formulated for oral use and contains guaifenesin 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 Precision Dose Inc. on March 22, 2023. The current certification is valid through December 31, 2026.

How is this Precision Dose Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68094004861. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
68094-048-61
11-Digit CMS (5-4-2)
68094-0048-61

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