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  5. NDC Package Code: 58602-804-83 Pseudoephedrine Hcl

NDC Package 58602-804-83 Pseudoephedrine Hcl

Tablet, Extended Release 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:
58602-804-83
Package Description:
1 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
58602-804
Proprietary Name:
Pseudoephedrine Hcl
Non-Proprietary Name:
Pseudoephedrine Hcl
Substance Name:
Pseudoephedrine Hydrochloride
Usage Information:
Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion. If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product in children younger than 6 years unless specifically directed by the doctor. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar decongestants (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
11-Digit NDC Billing Format:
58602080483
NDC to RxNorm Crosswalk:
  • RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1049154 - 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet
Product Type:
Human Otc Drug
Labeler Name:
Aurohealth Llc
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA209008
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-09-2017
Listing Expiration Date:
12-31-2026
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
58602-804-672 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 58602-804-83?

The NDC Packaged Code 58602-804-83 is assigned to a package of 1 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack of Pseudoephedrine Hcl, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is tablet, extended release and is administered via oral form.

Is NDC 58602-804 included in the NDC Directory?

Yes, Pseudoephedrine Hcl with product code 58602-804 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on June 09, 2017 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58602-804-83?

The 11-digit format is 58602080483. 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
5-3-258602-804-835-4-258602-0804-83