Nicardipine Hydrochloride Capsule
NDC Package 35573-458-85

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

Package Information

Nicardipine Hydrochloride capsules is i. This formulation utilizes a capsule delivery system. Marketed by Burel Pharmaceuticals, Llc, this product is identified by NDC 35573-458 and is authorized under FDA application ANDA215377.

Identification & Billing

NDC Package Code
35573-458-85
Package Description
90 CAPSULE in 1 BOTTLE
Product Code
35573-458
11-Digit Billing Format
35573045885
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicardipine Hydrochloride
Non-Proprietary Name
Nicardipine Hydrochloride
Substance Name
Nicardipine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NICARDIPINE HYDROCHLORIDE 30 mg/1
Pharmacologic Class
Usage Information
I. Stable AnginaNicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers.II. HypertensionNicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (See DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Burel Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215377
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2023
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 35573-458-85 identifies a specific commercial package of 90 capsule in 1 bottle of Nicardipine Hydrochloride, a human prescription drug labeled by Burel Pharmaceuticals, Llc. This capsule is formulated for oral 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 Burel Pharmaceuticals, Llc on January 08, 2023. The current certification is valid through December 31, 2026.

How is this Burel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573045885. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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)
35573-458-85
11-Digit CMS (5-4-2)
35573-0458-85

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