Diltiazem Hydrochloride
NDC Package 42291-059-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Diltiazem Hydrochloride is a . Marketed by Avkare, this product is identified by NDC 42291-059 and is authorized under FDA application ANDA212317.

Identification & Billing

NDC Package Code
42291-059-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
42291-059
11-Digit Billing Format
42291005901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Diltiazem Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Avkare
FDA Application #
ANDA212317
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-30-2023
End Marketing Date
09-13-2023
Listing Expiration
09-13-2023
Exclude Flag
D
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 42291-059-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Diltiazem Hydrochloride, labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Avkare on March 30, 2023. The current certification is valid through September 13, 2023.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291005901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
42291-059-01
11-Digit CMS (5-4-2)
42291-0059-01

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