Giapreza Injection
NDC Package 68547-005-01

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

Package Information

Giapreza (angiotensin ii) injection is gIAPREZA increases blood pressure in adults with septic or other distributive shock. This formulation utilizes a injection delivery system. Marketed by La Jolla Pharmaceutical Company, this product is identified by NDC 68547-005 and is authorized under FDA application NDA209360.

Identification & Billing

NDC Package Code
68547-005-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
68547-005
11-Digit Billing Format
68547000501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Giapreza
Non-Proprietary Name
Angiotensin Ii
Substance Name
Angiotensin Ii
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ANGIOTENSIN II .5 mg/mL
Pharmacologic Class
Usage Information
GIAPREZA increases blood pressure in adults with septic or other distributive shock.

Regulatory & Marketing

Labeler Name
La Jolla Pharmaceutical Company
Product Type
Human Prescription Drug
FDA Application #
NDA209360
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-15-2022
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 68547-005-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Giapreza, a human prescription drug labeled by La Jolla Pharmaceutical Company. This injection is formulated for intravenous use and contains angiotensin ii 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 La Jolla Pharmaceutical Company on September 15, 2022. The current certification is valid through December 31, 2026.

How is this La Jolla Pharmaceutical Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68547000501. 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)
68547-005-01
11-Digit CMS (5-4-2)
68547-0005-01

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