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  5. NDC Package Code: 58602-814-10 Diphenhydramine Hcl And Ibuprofen

NDC Package 58602-814-10 Diphenhydramine Hcl And Ibuprofen

Capsule, Liquid Filled 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:
58602-814-10
Package Description:
1 BOTTLE in 1 CARTON / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
58602-814
Proprietary Name:
Diphenhydramine Hcl And Ibuprofen
Non-Proprietary Name:
Diphenhydramine Hcl And Ibuprofen
Substance Name:
Diphenhydramine Hydrochloride; 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 informationeach capsule contains: potassium 20 mgread 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)protect from lightOrganic Impurities Test is PendingUSP Dissolution Test is pending
11-Digit NDC Billing Format:
58602081410
NDC to RxNorm Crosswalk:
  • RxCUI: 901814 - ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral Capsule
  • RxCUI: 901814 - diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Aurohealth Llc
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 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:
    ANDA210676
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-14-2019
    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
    58602-814-121 BOTTLE in 1 CARTON / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
    58602-814-181 BOTTLE in 1 CARTON / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
    58602-814-23120 CAPSULE, LIQUID FILLED in 1 BOTTLE
    58602-814-30160 CAPSULE, LIQUID FILLED in 1 BOTTLE
    58602-814-731 BOTTLE in 1 CARTON / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58602-814-10?

    The NDC Packaged Code 58602-814-10 is assigned to a package of 1 bottle in 1 carton / 32 capsule, liquid filled in 1 bottle of Diphenhydramine Hcl And Ibuprofen, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 58602-814 included in the NDC Directory?

    Yes, Diphenhydramine Hcl And Ibuprofen with product code 58602-814 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on February 14, 2019 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 58602-814-10?

    The 11-digit format is 58602081410. 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
    5-3-258602-814-105-4-258602-0814-10