Sanaflu Xtra Capsule, Gelatin Coated
NDC Package 48201-001-12

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

Package Information

Sanaflu Xtra (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride) capsules is adults and children 12 years of age and older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours.Children under 12 years of age: Consult a doctor. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Grandall Distributing, Llc, this product is identified by NDC 48201-001 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
48201-001-12
Package Description
12 CAPSULE, GELATIN COATED in 1 BOX
Product Code
48201-001
11-Digit Billing Format
48201000112
RxNorm Crosswalk
  • RxCUI: 1193292 - acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1193292 - acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1193292 - APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Sanaflu Xtra
Non-Proprietary Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
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 older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours.Children under 12 years of age: Consult a doctor.

Regulatory & Marketing

Labeler Name
Grandall Distributing, Llc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-30-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48201-001-12 identifies a specific commercial package of 12 capsule, gelatin coated in 1 box of Sanaflu Xtra, a human over the counter drug labeled by Grandall Distributing, Llc. This capsule, gelatin coated is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide; phenylephrine 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 Grandall Distributing, Llc on April 30, 2015. The current certification is valid through December 31, 2026.

How is this Grandall Distributing, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48201000112. 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)
48201-001-12
11-Digit CMS (5-4-2)
48201-0001-12

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