Diltiazem Hydrochloride Injection, Powder, Lyophilized, For Solution
NDC Package 0409-4350-03

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

Package Information

Diltiazem Hydrochloride injection is or Diltiazem Hydrochloride for Injection are indicated for the following:. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Hospira, Inc., this product is identified by NDC 0409-4350 and is authorized under FDA application ANDA075853.

Identification & Billing

NDC Package Code
0409-4350-03
Package Description
10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-4350-13)
Product Code
0409-4350
11-Digit Billing Format
00409435003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diltiazem Hydrochloride
Non-Proprietary Name
Diltiazem Hydrochloride
Substance Name
Diltiazem Hydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DILTIAZEM HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Usage Information
Diltiazem Hydrochloride Injection or Diltiazem Hydrochloride for Injection are indicated for the following:

Regulatory & Marketing

Labeler Name
Hospira, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075853
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2005
End Marketing Date
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 0409-4350-03 identifies a specific commercial package of 10 vial, patent delivery system in 1 tray / 1 injection, powder, lyophilized, for solution in 1 vial, patent delivery system (0409-4350-13) of Diltiazem Hydrochloride, a human prescription drug labeled by Hospira, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains diltiazem 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 Hospira, Inc. on April 30, 2005.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409435003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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 (4-4-2)
0409-4350-03
11-Digit CMS (5-4-2)
00409-4350-03

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