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  5. NDC Package Code: 68382-384-01 Desmopressin Acetate

NDC Package 68382-384-01 Desmopressin Acetate

Spray Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
68382-384-01
Package Description:
5 mL in 1 BOTTLE, SPRAY
Product Code:
68382-384
Proprietary Name:
Desmopressin Acetate
Non-Proprietary Name:
Desmopressin Acetate
Substance Name:
Desmopressin Acetate
Usage Information:
Desmopressin is used to control the amount of urine your kidneys make. Normally, the amount of urine you make is controlled by a certain substance in the body called vasopressin. In people who have "water diabetes" (diabetes insipidus) or certain kinds of head injury or brain surgery, the body does not make enough vasopressin. Desmopressin is a man-made form of vasopressin and is used to replace a low level of vasopressin. This medication helps to control increased thirst and too much urination due to these conditions, and helps prevent dehydration. Desmopressin products applied in the nose are no longer indicated to control nighttime bedwetting in children because of the increased risk of developing a serious side effect (a low level of sodium in the blood).
11-Digit NDC Billing Format:
68382038401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
5 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 849506 - desmopressin acetate 0.01 % Nasal Spray
  • RxCUI: 849506 - desmopressin acetate 0.01 MG/ACTUAT Nasal Spray
  • RxCUI: 849506 - desmopressin acetate 10 MCG per 0.1 ML Nasal Spray
  • RxCUI: 849506 - desmopressin acetate 10 MCG/ACTUAT Nasal Spray
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals Usa Inc.
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • DESMOPRESSIN ACETATE .1 mg/mL
    • Pharmacologic Class(es):
  • Factor VIII Activator - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor VIII Activity - [PE] (Physiologic Effect)
  • Increased Coagulation Factor VIII Concentration - [PE] (Physiologic Effect)
  • Vasopressin Analog - [EPC] (Established Pharmacologic Class)
  • Vasopressins - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA091345
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-01-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Frequently Asked Questions

    What is NDC 68382-384-01?

    The NDC Packaged Code 68382-384-01 is assigned to a package of 5 ml in 1 bottle, spray of Desmopressin Acetate, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is spray and is administered via nasal form.

    Is NDC 68382-384 included in the NDC Directory?

    Yes, Desmopressin Acetate with product code 68382-384 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on February 01, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68382-384-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 5.

    What is the 11-digit format for NDC 68382-384-01?

    The 11-digit format is 68382038401. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268382-384-015-4-268382-0384-01