Diltiazem Hydrochloride
NDC Package 68258-6046-3

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 inactivated by the FDA.

Diltiazem Hydrochloride is extended-release capsules, USP are indicated for the treatment of hypertension. Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-6046 and is authorized under FDA application ANDA074984.

Identification & Billing

NDC Package Code
68258-6046-3
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
68258-6046
11-Digit Billing Format
68258604603
RxNorm Crosswalk
  • RxCUI: 830845 - dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule
  • RxCUI: 830845 - 24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule
  • RxCUI: 830845 - diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Diltiazem Hydrochloride
Dosage Form
-
Usage Information
Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

Regulatory & Marketing

Labeler Name
Dispensing Solutions, Inc.
FDA Application #
ANDA074984
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-20-1999
Listing Expiration
12-31-2017
Exclude Flag
I
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 68258-6046-3 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Diltiazem Hydrochloride, labeled by Dispensing Solutions, Inc.. 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 Dispensing Solutions, Inc. on December 20, 1999. The current certification is valid through December 31, 2017.

How is this Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258604603. 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 (5-4-1)
68258-6046-3
11-Digit CMS (5-4-2)
68258-6046-03

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