Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
NDC Package 55111-798-41

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

Package Information

Guaifenesin And Pseudoephedrine Hcl tablets is ■ do not crush, chew, or break tablet■ take with a full glass of water■ this product can be administered without regard for timing of meals■ children under 12 years of age: do not useFor 600 mg/60 mg■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours For 1200 mg/120 mg■ adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours. This formulation utilizes a tablet, extended release delivery system. Marketed by Dr. Reddys Laboratories Limited, this product is identified by NDC 55111-798 and is authorized under FDA application ANDA208369.

Identification & Billing

NDC Package Code
55111-798-41
Package Description
2 BLISTER PACK in 1 CARTON / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
55111-798
11-Digit Billing Format
55111079841
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
  • RxCUI: 1244675 - guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1244675 - 12 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1305603 - guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1305603 - 12 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral Tablet
  • RxCUI: 1305603 - guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Guaifenesin And Pseudoephedrine Hcl
Non-Proprietary Name
Guaifenesin And Pseudoephedrine Hcl
Substance Name
Guaifenesin; Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
■ do not crush, chew, or break tablet■ take with a full glass of water■ this product can be administered without regard for timing of meals■ children under 12 years of age: do not useFor 600 mg/60 mg■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours For 1200 mg/120 mg■ adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours

Regulatory & Marketing

Labeler Name
Dr. Reddys Laboratories Limited
Product Type
Human Otc Drug
FDA Application #
ANDA208369
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55111-798). Click a package code to view its specific billing and regulatory data.

55111-798-09
1 BLISTER PACK in 1 CARTON / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
55111-798-18
2 BLISTER PACK in 1 CARTON / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
55111-798-35
1 BLISTER PACK in 1 CARTON / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
55111-798-36
4 BLISTER PACK in 1 CARTON / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
55111-798-77
6 BLISTER PACK in 1 CARTON / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 55111-798-41 identifies a specific commercial package of 2 blister pack in 1 carton / 18 tablet, extended release in 1 blister pack of Guaifenesin And Pseudoephedrine Hcl, a human over the counter drug labeled by Dr. Reddys Laboratories Limited. This tablet, extended release is formulated for oral use and contains guaifenesin; pseudoephedrine 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 Dr. Reddys Laboratories Limited on December 29, 2017. The current certification is valid through December 31, 2026.

How is this Dr. Reddys Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111079841. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
55111-798-41
11-Digit CMS (5-4-2)
55111-0798-41

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