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  5. NDC Package Code: 55758-304-04 Dolex Children

NDC Package 55758-304-04 Dolex Children

Ibuprofen Liquid 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:
55758-304-04
Package Description:
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code:
55758-304
Proprietary Name:
Dolex Children
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:
55758030404
Product Type:
Human Otc Drug
Labeler Name:
Pharmadel Llc
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
IBUPROFEN 100 mg/100mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA210602
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-07-2020
Listing Expiration Date:
12-31-2025
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 55758-304-04?

The NDC Packaged Code 55758-304-04 is assigned to a package of 1 bottle in 1 carton / 118 ml in 1 bottle of Dolex Children, a human over the counter drug labeled by Pharmadel Llc. The product's dosage form is liquid and is administered via oral form.

Is NDC 55758-304 included in the NDC Directory?

Yes, Dolex Children with product code 55758-304 is active and included in the NDC Directory. The product was first marketed by Pharmadel Llc on August 07, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 55758-304-04?

The 11-digit format is 55758030404. 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
5-3-255758-304-045-4-255758-0304-04