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  5. NDC Package Code: 36800-057-05 Topcare Infants Ibuprofen

NDC Package 36800-057-05 Topcare Infants Ibuprofen

Ibuprofen Suspension 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:
36800-057-05
Package Description:
1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE
Product Code:
36800-057
Proprietary Name:
Topcare Infants Ibuprofen
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:
36800005705
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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:
    Topco Associates Llc
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    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:
    ANDA075217
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-22-2002
    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 36800-057-05?

    The NDC Packaged Code 36800-057-05 is assigned to a package of 1 bottle in 1 carton / 15 ml in 1 bottle of Topcare Infants Ibuprofen, a human over the counter drug labeled by Topco Associates Llc. The product's dosage form is suspension and is administered via oral form.

    Is NDC 36800-057 included in the NDC Directory?

    Yes, Topcare Infants Ibuprofen with product code 36800-057 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on January 22, 2002 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 NDC billing unit for package 36800-057-05?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 36800-057-05?

    The 11-digit format is 36800005705. 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
    5-3-236800-057-055-4-236800-0057-05