1. Home
  2. Labeler Index
  3. Gm Pharmaceuticals, Inc.
  4. 58809-198
  5. NDC Package Code: 58809-198-60 Vanatab Dm

NDC Package 58809-198-60 Vanatab Dm

Dextromethorphan Hbr,Guaifenesin,Phenylephrine Hcl Tablet Oral - 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:
58809-198-60
Package Description:
60 TABLET in 1 BOTTLE, PLASTIC
Product Code:
58809-198
Proprietary Name:
Vanatab Dm
Non-Proprietary Name:
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Do not exceed recommended dosage.Adults and children12 years of ageand over:2 tablets every 4 hours, not to exceed 6 doses in 24 hoursChildren 6 to under12 years of age:1 tablet every 4 hours, not to exceed 6 doses in 24 hoursChildren under 6 yearsof age:Consult a doctor.
11-Digit NDC Billing Format:
58809019860
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1874730 - dextromethorphan HBr 9 MG / guaiFENesin 198 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1874730 - dextromethorphan hydrobromide 9 MG / guaifenesin 198 MG / phenylephrine hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Gm Pharmaceuticals, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN HYDROBROMIDE 9 mg/1
  • GUAIFENESIN 198 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • 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)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    03-01-2017
    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 58809-198-60?

    The NDC Packaged Code 58809-198-60 is assigned to a package of 60 tablet in 1 bottle, plastic of Vanatab Dm, a human over the counter drug labeled by Gm Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

    Is NDC 58809-198 included in the NDC Directory?

    Yes, Vanatab Dm with product code 58809-198 is active and included in the NDC Directory. The product was first marketed by Gm Pharmaceuticals, Inc. on March 01, 2017 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 NDC billing unit for package 58809-198-60?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 58809-198-60?

    The 11-digit format is 58809019860. 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
    5-3-258809-198-605-4-258809-0198-60