Guaifenesin And Dextromethorphan Hbr Tablet, Extended Release
NDC Package 51316-009-01

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

Package Information

Guaifenesin And Dextromethorphan Hbr 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/30 mg:adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours. This formulation utilizes a tablet, extended release delivery system. Marketed by Cvs Pharmacy, this product is identified by NDC 51316-009 and is authorized under FDA application ANDA217340.

Identification & Billing

NDC Package Code
51316-009-01
Package Description
5 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
51316-009
11-Digit Billing Format
51316000901
RxNorm Crosswalk
  • RxCUI: 1298324 - guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1298324 - 12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet
  • RxCUI: 1298324 - dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Guaifenesin And Dextromethorphan Hbr
Non-Proprietary Name
Guaifenesin And Dextromethorphan Hbr
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
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/30 mg:adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.

Regulatory & Marketing

Labeler Name
Cvs Pharmacy
Product Type
Human Otc Drug
FDA Application #
ANDA217340
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-15-2023
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 51316-009-01 identifies a specific commercial package of 5 blister pack in 1 carton / 20 tablet, extended release in 1 blister pack of Guaifenesin And Dextromethorphan Hbr, a human over the counter drug labeled by Cvs Pharmacy. This tablet, extended release is formulated for oral use and contains dextromethorphan hydrobromide; 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 Cvs Pharmacy on August 15, 2023. The current certification is valid through December 31, 2026.

How is this Cvs Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316000901. 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)
51316-009-01
11-Digit CMS (5-4-2)
51316-0009-01

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