Duraflu Tablet
NDC Package 50991-535-01

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

Duraflu (acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl) tablets is adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours or as directed by a doctorChildren under 12 years of age½ tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctorWhen using this product do not exceed recommended dosage. This formulation utilizes a tablet delivery system. Marketed by Poly Pharmaceuticals, Inc., this product is identified by NDC 50991-535 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50991-535-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
50991-535
11-Digit Billing Format
50991053501
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: 1673869 - acetaminophen 325 MG / dextromethorphan HBr 20 MG / guaiFENesin 200 MG / pseudoephedrine HCl 60 MG Oral Tablet
  • RxCUI: 1673869 - acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
  • RxCUI: 1673869 - APAP 325 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 200 MG / Pseudoephedrine Hydrochloride 60 MG Oral Tablet

Clinical Specifications

Proprietary Name
Duraflu
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours or as directed by a doctorChildren under 12 years of age½ tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctorWhen using this product do not exceed recommended dosage.

Regulatory & Marketing

Labeler Name
Poly Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2015
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 (50991-535). Click a package code to view its specific billing and regulatory data.

50991-535-02
6 BLISTER PACK in 1 CARTON / 2 TABLET 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 50991-535-01 identifies a specific commercial package of 100 tablet in 1 bottle of Duraflu, a human over the counter drug labeled by Poly Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; 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 Poly Pharmaceuticals, Inc. on October 01, 2015. The current certification is valid through December 31, 2026.

How is this Poly Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50991053501. 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)
50991-535-01
11-Digit CMS (5-4-2)
50991-0535-01

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