NDC Package 61786-991-03 Loratadine Antihistamine

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

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:

61786-991-03

Package Description:

20 TABLET in 1 BOTTLE

Product Code:

61786-991

Proprietary Name:

Loratadine Antihistamine

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.

11-Digit NDC Billing Format:

61786099103

Labeler Name:

Remedyrepack Inc.

Sample Package:

FDA Application Number:

ANDA076301

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

11-15-2016

End Marketing Date:

10-26-2018

Listing Expiration Date:

10-26-2018

Exclude Flag:

Code Structure:

61786 - Remedyrepack Inc.
- 61786-991 - Loratadine
  - 61786-991-03 - 20 TABLET in 1 BOTTLE

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 Code	Package Description
61786-991-02	30 TABLET in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61786-991-03?

The NDC Packaged Code 61786-991-03 is assigned to a package of 20 tablet in 1 bottle of Loratadine Antihistamine, labeled by Remedyrepack Inc.. The product's dosage form is and is administered via form.

Is NDC 61786-991 included in the NDC Directory?

The product was first marketed by Remedyrepack Inc. on November 15, 2016 and its listing in the NDC Directory is set to expire on October 26, 2018 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61786-991-03?

The 11-digit format is 61786099103. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	61786-991-03	5-4-2	61786-0991-03

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