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  5. NDC Package Code: 51660-058-18 Guaifenesin And Pseudoephedrine Hcl

NDC Package 51660-058-18 Guaifenesin And Pseudoephedrine Hcl

Tablet, Extended Release 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:
51660-058-18
Package Description:
1 BLISTER PACK in 1 CARTON / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
51660-058
Proprietary Name:
Guaifenesin And Pseudoephedrine Hcl
Non-Proprietary Name:
Guaifenesin And Pseudoephedrine Hcl
Substance Name:
Guaifenesin; Pseudoephedrine
Usage Information:
•do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•For 600 mg/60 mg: adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours•For 1200 mg/120 mg: adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours•children under 12 years of age: do not use
11-Digit NDC Billing Format:
51660005818
NDC to RxNorm Crosswalk:
  • RxCUI: 1244675 - guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1244675 - 12 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1305603 - guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1305603 - 12 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral Tablet
  • RxCUI: 1305603 - guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Ohm Laboratories, Inc.
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GUAIFENESIN 600 mg/1
  • PSEUDOEPHEDRINE 60 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA212542
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2021
    Listing Expiration Date:
    12-31-2024
    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 51660-058-18?

    The NDC Packaged Code 51660-058-18 is assigned to a package of 1 blister pack in 1 carton / 18 tablet, extended release in 1 blister pack of Guaifenesin And Pseudoephedrine Hcl, a human over the counter drug labeled by Ohm Laboratories, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 51660-058 included in the NDC Directory?

    Yes, Guaifenesin And Pseudoephedrine Hcl with product code 51660-058 is active and included in the NDC Directory. The product was first marketed by Ohm Laboratories, Inc. on April 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 51660-058-18?

    The 11-digit format is 51660005818. 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
    5-3-251660-058-185-4-251660-0058-18