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  5. NDC Package Code: 48201-001-12 Sanaflu Xtra

NDC Package 48201-001-12 Sanaflu Xtra

Acetaminophen,Chlorpheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
48201-001-12
Package Description:
12 CAPSULE, GELATIN COATED in 1 BOX
Product Code:
48201-001
Proprietary Name:
Sanaflu Xtra
Non-Proprietary Name:
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Substance Name:
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
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.
11-Digit NDC Billing Format:
48201000112
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Grandall Distributing, Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 250 mg/1
  • CHLORPHENIRAMINE MALEATE 2 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • 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)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M013
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    04-30-2015
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 48201-001-12?

    The NDC Packaged Code 48201-001-12 is assigned to a package of 12 capsule, gelatin coated in 1 box of Sanaflu Xtra, a human over the counter drug labeled by Grandall Distributing, Llc. The product's dosage form is capsule, gelatin coated and is administered via oral form.

    Is NDC 48201-001 included in the NDC Directory?

    Yes, Sanaflu Xtra with product code 48201-001 is active and included in the NDC Directory. The product was first marketed by Grandall Distributing, Llc on April 30, 2015 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 48201-001-12?

    The 11-digit format is 48201000112. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-248201-001-125-4-248201-0001-12