Nicardipine Hydrochloride Injection
NDC Package 82432-103-01

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

Package Information

Nicardipine Hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. This formulation utilizes a injection delivery system. Marketed by Chengdu Shuode Pharmaceutical Co., Ltd, this product is identified by NDC 82432-103 and is authorized under FDA application ANDA217548.

Identification & Billing

NDC Package Code
82432-103-01
Package Description
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code
82432-103
11-Digit Billing Format
82432010301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicardipine Hydrochloride
Non-Proprietary Name
Nicardipine Hydrochloride
Substance Name
Nicardipine Hydrochloride
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)
NICARDIPINE HYDROCHLORIDE 25 mg/10mL
Pharmacologic Class
Usage Information
Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6)].

Regulatory & Marketing

Labeler Name
Chengdu Shuode Pharmaceutical Co., Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA217548
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-11-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82432-103). Click a package code to view its specific billing and regulatory data.

82432-103-02
10 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS

* 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 82432-103-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass of Nicardipine Hydrochloride, a human prescription drug labeled by Chengdu Shuode Pharmaceutical Co., Ltd. This injection is formulated for intravenous use and contains nicardipine hydrochloride 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 Chengdu Shuode Pharmaceutical Co., Ltd on September 11, 2024. The current certification is valid through December 31, 2026.

How is this Chengdu Shuode Pharmaceutical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82432010301. 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)
82432-103-01
11-Digit CMS (5-4-2)
82432-0103-01

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