Desmopressin Acetate Solution
NDC Package 68682-342-05

11-digit billing NDC: 68682034205 · Billing unit: ML · 5 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Desmopressin Acetate solution is desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older.Limitations of Use:Desmopressin nasal spray solution is not indicated for:•Treatment of nephrogenic diabetes insipidus,•Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)],•Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)],•Use in patients with an impaired level of consciousness,•Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths(3)]. This formulation utilizes a solution delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-342 and is authorized under FDA application ANDA074830.

Identification & Billing

NDC Package Code
68682-342-05
Package Description
1 BOTTLE, PUMP in 1 CARTON / 5 mL in 1 BOTTLE, PUMP
Product Code
68682-342
11-Digit Billing Format
68682034205
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Desmopressin Acetate
Non-Proprietary Name
Desmopressin Acetate
Substance Name
Desmopressin Acetate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
DESMOPRESSIN ACETATE .1 mg/mL
Pharmacologic Class
Usage Information
Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older.Limitations of Use:Desmopressin nasal spray solution is not indicated for:•Treatment of nephrogenic diabetes insipidus,•Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)],•Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)],•Use in patients with an impaired level of consciousness,•Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths(3)]

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA074830
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2025
End Marketing Date
01-31-2028
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 68682-342-05 identifies a specific commercial package of 1 bottle, pump in 1 carton / 5 ml in 1 bottle, pump of Desmopressin Acetate, a human prescription drug labeled by Oceanside Pharmaceuticals. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This solution is formulated for nasal 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 Oceanside Pharmaceuticals on June 01, 2025.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682034205. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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)
68682-342-05
11-Digit CMS (5-4-2)
68682-0342-05

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