Desmopressin Acetate Tablet
NDC Package 51655-461-52

11-digit billing NDC: 51655046152
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Desmopressin Acetate tablets is central Diabetes InsipidusDesmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. This formulation utilizes a tablet delivery system. Marketed by Northwind Health Company, Llc, this product is identified by NDC 51655-461 and is authorized under FDA application ANDA210371.

Identification & Billing

NDC Package Code
51655-461-52
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
51655-461
11-Digit Billing Format
51655046152
RxNorm Crosswalk
RxCUI: 833008 - desmopressin acetate 0.2 MG Oral Tablet

Clinical Specifications

Proprietary Name
Desmopressin Acetate
Non-Proprietary Name
Desmopressin Acetate
Substance Name
Desmopressin Acetate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DESMOPRESSIN ACETATE .2 mg/1
Pharmacologic Class
Usage Information
Central Diabetes InsipidusDesmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus.Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.Primary Nocturnal EnuresisDesmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. Desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.

Regulatory & Marketing

Labeler Name
Northwind Health Company, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA210371
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-29-2020
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51655-461-52 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Desmopressin Acetate, a human prescription drug labeled by Northwind Health Company, Llc. This tablet is formulated for oral use and contains desmopressin acetate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Northwind Health Company, Llc on October 29, 2020. The current certification is valid through December 31, 2027.

How is this Northwind Health Company, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51655046152. 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)
51655-461-52
11-Digit CMS (5-4-2)
51655-0461-52

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