Noctiva
NDC Package 71758-107-56

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Noctiva is desmopressin is a man-made form of vasopressin. Marketed by Avadel Specialty Pharmaceuticals, Llc, this product is identified by NDC 71758-107 and is authorized under FDA application NDA201656.

Identification & Billing

NDC Package Code
71758-107-56
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 30 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
71758-107
11-Digit Billing Format
71758010756

Clinical Specifications

Proprietary Name
Noctiva
Dosage Form
-
Usage Information
Desmopressin is a man-made form of vasopressin. Vasopressin is a substance in your body that helps control how much urine you make. This medication is used by adults who wake up 2 or more times during the night to urinate due to a condition called nocturnal polyuria. This is a condition where your body makes too much urine at night. Other conditions can also cause you to wake up at night to urinate, so you will receive this treatment only after tests by your doctor show you have this condition. Do not use this medication to treat children who wet the bed at night.

Regulatory & Marketing

Labeler Name
Avadel Specialty Pharmaceuticals, Llc
FDA Application #
NDA201656
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-08-2017
End Marketing Date
03-31-2020
Listing Expiration
03-31-2020
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 (71758-107). Click a package code to view its specific billing and regulatory data.

71758-107-55
1 BOTTLE, SPRAY in 1 CARTON / 30 SPRAY, METERED in 1 BOTTLE, SPRAY

* 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 71758-107-56 identifies a specific commercial package of 1 bottle, spray in 1 carton / 30 spray, metered in 1 bottle, spray of Noctiva, labeled by Avadel Specialty Pharmaceuticals, Llc. 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 Avadel Specialty Pharmaceuticals, Llc on December 08, 2017. The current certification is valid through March 31, 2020.

What are the primary indications for this medication?

Desmopressin is a man-made form of vasopressin. Vasopressin is a substance in your body that helps control how much urine you make. This medication is used by adults who wake up 2 or more times during the night to urinate due to a condition called nocturnal polyuria. This is a condition where your body makes too much urine at night. Other conditions can also cause you to wake up at night to urinate, so you will receive this treatment only after tests by your doctor show you have this condition. Do not use this medication to treat children who wet the bed at night.

How is this Avadel Specialty Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71758010756. 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)
71758-107-56
11-Digit CMS (5-4-2)
71758-0107-56

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