Pseudoephedrine Hcl
NDC Package 50844-211-14
Package Information
Pseudoephedrine Hcl is 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). Marketed by L.n.k. International, Inc., this product is identified by NDC 50844-211 and is authorized under FDA application part341.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50844 - L.n.k. International, Inc.
- 50844-211 - Pseudoephedrine Hcl
- 50844-211-14 - 500 TABLET, FILM COATED in 1 BOTTLE, DISPENSING
- 50844-211 - Pseudoephedrine Hcl
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 50844-211-14 identifies a specific commercial package of 500 tablet, film coated in 1 bottle, dispensing of Pseudoephedrine Hcl, labeled by L.n.k. International, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by L.n.k. International, Inc. on June 29, 2018. The current certification is valid through August 22, 2023.
What are the primary indications for this medication?
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).
How is this L.n.k. International, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50844021114. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.