Nicardipine Hydrochloride Injection
NDC Package 42571-394-89

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

Package Information

Nicardipine Hydrochloride injection is  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 Micro Labs Limited, this product is identified by NDC 42571-394 and is authorized under FDA application ANDA216420.

Identification & Billing

NDC Package Code
42571-394-89
Package Description
10 VIAL in 1 CARTON / 10 mL in 1 VIAL (42571-394-88)
Product Code
42571-394
11-Digit Billing Format
42571039489
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 2.5 mg/mL
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
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA216420
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42571-394-89 identifies a specific commercial package of 10 vial in 1 carton / 10 ml in 1 vial (42571-394-88) of Nicardipine Hydrochloride, a human prescription drug labeled by Micro Labs Limited. 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 Micro Labs Limited on November 01, 2023. The current certification is valid through December 31, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571039489. 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)
42571-394-89
11-Digit CMS (5-4-2)
42571-0394-89

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