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  5. NDC Package Code: 53041-637-09 Concentrated Ibuprofen Infants

NDC Package 53041-637-09 Concentrated Ibuprofen Infants

Ibuprofen Suspension/ Drops 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:
53041-637-09
Package Description:
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code:
53041-637
Proprietary Name:
Concentrated Ibuprofen Infants
Non-Proprietary Name:
Ibuprofen
Substance Name:
Ibuprofen
Usage Information:
Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.
11-Digit NDC Billing Format:
53041063709
NDC to RxNorm Crosswalk:
  • RxCUI: 204442 - ibuprofen 50 MG in 1.25 mL Oral Suspension
  • RxCUI: 204442 - ibuprofen 40 MG/ML Oral Suspension
  • RxCUI: 204442 - ibuprofen 50 MG per 1.25 ML Oral Suspension
  • RxCUI: 204442 - ibuprofen 50 MG per 1.25 ML Oral Suspension Drops
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Guardian Drug Company
    Dosage Form:
    Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • IBUPROFEN 50 mg/1.25mL
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210755
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-03-2018
    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 53041-637-09?

    The NDC Packaged Code 53041-637-09 is assigned to a package of 1 bottle in 1 carton / 30 ml in 1 bottle of Concentrated Ibuprofen Infants, a human over the counter drug labeled by Guardian Drug Company. The product's dosage form is suspension/ drops and is administered via oral form.

    Is NDC 53041-637 included in the NDC Directory?

    Yes, Concentrated Ibuprofen Infants with product code 53041-637 is active and included in the NDC Directory. The product was first marketed by Guardian Drug Company on October 03, 2018 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 53041-637-09?

    The 11-digit format is 53041063709. 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
    5-3-253041-637-095-4-253041-0637-09