Cosyntropin Injection, Powder, Lyophilized, For Solution
NDC Package 71872-7313-1

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

Package Information

Cosyntropin injection is cosyntropin for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Medical Purchasing Solutions, Llc, this product is identified by NDC 71872-7313 and is authorized under FDA application ANDA202147.

Identification & Billing

NDC Package Code
71872-7313-1
Package Description
1 VIAL in 1 BAG / 1 mL in 1 VIAL
Product Code
71872-7313
11-Digit Billing Format
71872731301

Clinical Specifications

Proprietary Name
Cosyntropin
Non-Proprietary Name
Cosyntropin
Substance Name
Cosyntropin
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
COSYNTROPIN .25 mg/mL
Pharmacologic Class
Usage Information
Cosyntropin for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the adrenal cortex it may be utilized to perform a 30-minute test of adrenal function (plasma cortisol response) as an office or outpatient procedure, using only 2 venipunctures (see DOSAGE AND ADMINISTRATIONsection). Severe hypofunction of the pituitary - adrenal axis is usually associated with subnormal plasma cortisol values but a low basal level is not per se evidence of adrenal insufficiency and does not suffice to make the diagnosis. Many patients with proven insufficiency will have normal basal levels and will develop signs of insufficiency only when stressed. For this reason a criterion which should be used in establishing the diagnosis is the failure to respond to adequate corticotropin stimulation. When presumptive adrenal insufficiency is diagnosed by a subnormal Cosyntropin for Injection test, further studies are indicated to determine if it is primary or secondary.Primary adrenal insufficiency (Addison's disease) is the result of an intrinsic disease process, such as tuberculosis within the gland. The production of adrenocortical hormones is deficient despite high ACTH levels (feedback mechanism). Secondary or relative insufficiency arises as the result of defective production of ACTH leading in turn to disuse atrophy of the adrenal cortex. It is commonly seen, for example, as result of corticosteroid therapy, Sheehan's syndrome and pituitary tumors or ablation.The differentiation of both types is based on the premise that a primarily defective gland cannot be stimulated by ACTH whereas a secondarily defective gland is potentially functional and will respond to adequate stimulation with ACTH. Patients selected for further study as the result of a subnormal Cosyntropin for Injection test should be given a 3 or 4 day course of treatment with Repository Corticotropin Injection USP and then retested. Suggested doses are 40 USP units twice daily for 4 days or 60 USP units twice daily for 3 days. Under these conditions little or no increase in plasma cortisol levels will be seen in Addison's disease whereas higher or even normal levels will be seen in cases with secondary adrenal insufficiency.

Regulatory & Marketing

Labeler Name
Medical Purchasing Solutions, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202147
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-29-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71872-7313-1 identifies a specific commercial package of 1 vial in 1 bag / 1 ml in 1 vial of Cosyntropin, a human prescription drug labeled by Medical Purchasing Solutions, Llc. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains cosyntropin 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 Medical Purchasing Solutions, Llc on June 29, 2012. The current certification is valid through December 31, 2026.

How is this Medical Purchasing Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71872731301. 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 (5-4-1)
71872-7313-1
11-Digit CMS (5-4-2)
71872-7313-01

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