Desmopressin Acetate Injection, Solution
NDC Package 70095-031-01

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

Package Information

Desmopressin Acetate injection is desmopressin is used to control the amount of urine your kidneys make. This formulation utilizes a injection, solution delivery system. Marketed by Sun Pharmaceutical Industries Limited, this product is identified by NDC 70095-031 and is authorized under FDA application ANDA216904.

Identification & Billing

NDC Package Code
70095-031-01
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
70095-031
11-Digit Billing Format
70095003101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 849501 - desmopressin acetate 4 MCG/ML Injectable Solution
  • RxCUI: 849501 - desmopressin acetate 0.004 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Desmopressin Acetate
Non-Proprietary Name
Desmopressin Acetate
Substance Name
Desmopressin Acetate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
DESMOPRESSIN ACETATE 4 ug/mL
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA216904
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-20-2023
Listing Expiration
12-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2597
Source: PDAC
INJECTION, DESMOPRESSIN ACETATE, PER 1 MCG
HCPCS Dosage 1 MCG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 70095-031-01 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Desmopressin Acetate, a human prescription drug labeled by Sun Pharmaceutical Industries Limited. This injection, solution is formulated for intravenous; subcutaneous 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 Sun Pharmaceutical Industries Limited on June 20, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

How is this Sun Pharmaceutical Industries Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70095003101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
70095-031-01
11-Digit CMS (5-4-2)
70095-0031-01

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