NDC Package 61825-165-30 Doral

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

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

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:

61825-165-30

Package Description:

30 TABLET in 1 BOTTLE

Product Code:

61825-165

Proprietary Name:

Doral

Usage Information:

DORAL is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of DORAL has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of DORAL has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of DORAL Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.

11-Digit NDC Billing Format:

61825016530

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

Labeler Name:

Galt Pharmaceuticals, Llc

Sample Package:

FDA Application Number:

NDA018708

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

07-19-2017

End Marketing Date:

07-21-2024

Listing Expiration Date:

07-21-2024

Exclude Flag:

Code Structure:

61825 - Galt Pharmaceuticals, Llc
- 61825-165 - Doral
  - 61825-165-30 - 30 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
61825-165-10	100 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61825-165-30?

The NDC Packaged Code 61825-165-30 is assigned to a package of 30 tablet in 1 bottle of Doral, labeled by Galt Pharmaceuticals, Llc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 61825-165 included in the NDC Directory?

No, Doral with product code 61825-165 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Galt Pharmaceuticals, Llc on July 19, 2017 and its listing in the NDC Directory is set to expire on July 21, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61825-165-30?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 61825-165-30?

The 11-digit format is 61825016530. 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	61825-165-30	5-4-2	61825-0165-30

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