1. Home
  2. Labeler Index
  3. Aurohealth Llc
  4. 58602-867
  5. NDC Package Code: 58602-867-78 Ibuprofen And Diphenhydramine Citrate

NDC Package 58602-867-78 Ibuprofen And Diphenhydramine Citrate

Tablet, Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
58602-867-78
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code:
58602-867
Proprietary Name:
Ibuprofen And Diphenhydramine Citrate
Non-Proprietary Name:
Ibuprofen And Diphenhydramine Citrate
Substance Name:
Diphenhydramine Citrate; Ibuprofen
Usage Information:
Do not take more than directedadults and children 12 years and over: take 2 capsules at bedtimedo not take more than 2 capsules in 24 hoursOther informationread all warnings and directions before use. Keep carton.store at 20° to 25°C (68° to 77°F)avoid excessive heat above 40°C (104°F)
11-Digit NDC Billing Format:
58602086778
NDC to RxNorm Crosswalk:
  • RxCUI: 895664 - ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
  • RxCUI: 895664 - diphenhydramine citrate 38 MG / ibuprofen 200 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):
  • DIPHENHYDRAMINE CITRATE 38 mg/1
  • IBUPROFEN 200 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216204
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-31-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58602-867-091 BOTTLE in 1 CARTON / 30 TABLET, COATED in 1 BOTTLE
    58602-867-121 BOTTLE in 1 CARTON / 40 TABLET, COATED in 1 BOTTLE
    58602-867-141 BOTTLE in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE
    58602-867-181 BOTTLE in 1 CARTON / 80 TABLET, COATED in 1 BOTTLE
    58602-867-211 BOTTLE in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE
    58602-867-231 BOTTLE in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE
    58602-867-27140 TABLET, COATED in 1 BOTTLE
    58602-867-32180 TABLET, COATED in 1 BOTTLE
    58602-867-34200 TABLET, COATED in 1 BOTTLE
    58602-867-46140 TABLET, COATED in 1 BOTTLE, PLASTIC
    58602-867-701 BOTTLE, PLASTIC in 1 CARTON / 40 TABLET, COATED in 1 BOTTLE, PLASTIC
    58602-867-721 BOTTLE, PLASTIC in 1 CARTON / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
    58602-867-731 BOTTLE in 1 CARTON / 20 TABLET, COATED in 1 BOTTLE
    58602-867-80200 TABLET, COATED in 1 BOTTLE, PLASTIC
    58602-867-92180 TABLET, COATED in 1 BOTTLE, PLASTIC
    58602-867-97120 TABLET, COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58602-867-78?

    The NDC Packaged Code 58602-867-78 is assigned to a package of 1 bottle, plastic in 1 carton / 50 tablet, coated in 1 bottle, plastic of Ibuprofen And Diphenhydramine Citrate, 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 58602-867 included in the NDC Directory?

    Yes, Ibuprofen And Diphenhydramine Citrate with product code 58602-867 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on May 31, 2022 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 58602-867-78?

    The 11-digit format is 58602086778. 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
    5-3-258602-867-785-4-258602-0867-78