Diltiazem Hydrochloride
NDC Package 43353-906-79

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 diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-906 and is authorized under FDA application NDA020401.

Identification & Billing

NDC Package Code
43353-906-79
Package Description
2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
43353-906
11-Digit Billing Format
43353090679
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2160 EA
RxNorm Crosswalk
  • RxCUI: 830795 - dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Capsule
  • RxCUI: 830795 - 24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule
  • RxCUI: 830795 - diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 830801 - dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule
  • RxCUI: 830801 - 24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Diltiazem Hydrochloride
Dosage Form
-
Usage Information
Diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
NDA020401
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-25-2009
Listing Expiration
12-31-2019
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 43353-906-79 identifies a specific commercial package of 2160 capsule, extended release in 1 bottle, plastic of Diltiazem Hydrochloride, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2160 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 Aphena Pharma Solutions - Tennessee, Llc on September 25, 2009. The current certification is valid through December 31, 2019.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353090679. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2160 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)
43353-906-79
11-Digit CMS (5-4-2)
43353-0906-79

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