Guaifenesin Dm Tablet
NDC Package 43063-801-60
Package Information
Guaifenesin Dm (guaifenesin and dextromethorphan hydrobromide) tablets is temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common coldHelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucusHelps make coughs more productive.These highlights do not include all the information needed to use Guaifenesin DM, See full prescribing information for Guaifenesin DM Initial U.S. This formulation utilizes a tablet delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 43063-801 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1147685 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet
- RxCUI: 1147685 - dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet
- RxCUI: 1147685 - guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet
Clinical Specifications
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
Regulatory & Marketing
Hierarchy Structure
- 43063 - Pd-rx Pharmaceuticals, Inc.
- 43063-801 - Guaifenesin Dm
- 43063-801-60 - 60 TABLET in 1 BOTTLE, PLASTIC
- 43063-801 - Guaifenesin Dm
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 (43063-801). Click a package code to view its specific billing and regulatory data.
* 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 43063-801-60 identifies a specific commercial package of 60 tablet in 1 bottle, plastic of Guaifenesin Dm, a human over the counter drug labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet 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 Pd-rx Pharmaceuticals, Inc. on April 02, 2018.
How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43063080160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
