Loratadine
NDC Package 70934-467-97

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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 Denton Pharma, Inc. Dba Northwind Pharmaceuticals, this product is identified by NDC 70934-467 and is authorized under FDA application ANDA076301.

Identification & Billing

NDC Package Code
70934-467-97
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
70934046797
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Loratadine Antihistamine
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Denton Pharma, Inc. Dba Northwind Pharmaceuticals
FDA Application #
ANDA076301
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-26-2019
End Marketing Date
08-31-2021
Listing Expiration
08-31-2021
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70934-467). Click a package code to view its specific billing and regulatory data.

30 TABLET in 1 BOTTLE, PLASTIC
90 TABLET in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70934-467-97 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Loratadine Antihistamine, labeled by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 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 Denton Pharma, Inc. Dba Northwind Pharmaceuticals on November 26, 2019. The current certification is valid through August 31, 2021.

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 Denton Pharma, Inc. Dba Northwind Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70934046797. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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:

10-Digit Format (5-3-2)
70934-467-97
11-Digit CMS (5-4-2)
70934-0467-97

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.