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  5. NDC Package Code: 58602-839-13 Ibuprofen And Pseudoephedrine Hydrochloride

NDC Package 58602-839-13 Ibuprofen And Pseudoephedrine Hydrochloride

Tablet, Coated 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:
58602-839-13
Package Description:
4 BLISTER PACK in 1 CARTON / 8 TABLET, COATED in 1 BLISTER PACK
Product Code:
58602-839
Proprietary Name:
Ibuprofen And Pseudoephedrine Hydrochloride
Non-Proprietary Name:
Ibuprofen And Pseudoephedrine Hydrochloride
Substance Name:
Ibuprofen; Pseudoephedrine Hydrochloride
Usage Information:
Do not take more than directedthe smallest effective dose should be usedadults and children 12 years of age and over:take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.do not use more than 6 caplets in any 24-hour period unless directed by a doctorchildren under 12 years of age: do not useOther informationstore at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F).read all warnings and directions before use. Keep carton.
11-Digit NDC Billing Format:
58602083913
NDC to RxNorm Crosswalk:
  • RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral Tablet
  • RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Aurohealth Llc
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • IBUPROFEN 200 mg/1
  • PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213565
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-10-2023
    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 58602-839-13?

    The NDC Packaged Code 58602-839-13 is assigned to a package of 4 blister pack in 1 carton / 8 tablet, coated in 1 blister pack of Ibuprofen And Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 58602-839 included in the NDC Directory?

    Yes, Ibuprofen And Pseudoephedrine Hydrochloride with product code 58602-839 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on March 10, 2023 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 58602-839-13?

    The 11-digit format is 58602083913. 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
    5-3-258602-839-135-4-258602-0839-13