Loratadine
NDC Package 50436-3501-2
Package Information
Loratadine is a medication an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies. Marketed by Unit Dose Services, this product is identified by NDC 50436-3501 and is authorized under FDA application ANDA076301.
Identification & Billing
- RxCUI: 311372 - loratadine 10 MG 24HR Oral Tablet
- RxCUI: 311372 - loratadine 10 MG Oral Tablet
- RxCUI: 311372 - loratadine 10 MG 24 HR Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50436 - Unit Dose Services
- 50436-3501 - Loratadine
- 50436-3501-2 - 30 TABLET in 1 BOTTLE
- 50436-3501 - Loratadine
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 50436-3501-2 identifies a specific commercial package of 30 tablet in 1 bottle of Loratadine Antihistamine, labeled by Unit Dose Services. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 Unit Dose Services on October 15, 2008. The current certification is valid through December 31, 2019.
What are the primary indications for this medication?
This medication is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies. It is also used to relieve itching from hives. Loratadine does not prevent hives or prevent/treat a serious allergic reaction (anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use loratadine in place of your epinephrine. 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.) If you are using the tablets or capsules, do not use in children younger than 6 years unless directed by the doctor. If you are using the liquid or chewable tablets, do not use in children younger than 2 years unless directed by the doctor.
How is this Unit Dose Services product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436350102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 Package segment to maintain the 5-4-2 structure.