Diltiazem Hydrochloride Capsule, Extended Release
NDC Package 50742-252-10

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

Package Information

Diltiazem Hydrochloride capsules is diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. This formulation utilizes a capsule, extended release delivery system. Marketed by Ingenus Pharmaceuticals, Llc, this product is identified by NDC 50742-252 and is authorized under FDA application ANDA208783.

Identification & Billing

NDC Package Code
50742-252-10
Package Description
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
50742-252
11-Digit Billing Format
50742025210
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
Non-Proprietary Name
Diltiazem Hydrochloride
Substance Name
Diltiazem Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DILTIAZEM HYDROCHLORIDE 360 mg/1
Pharmacologic Class
Usage Information
Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

Regulatory & Marketing

Labeler Name
Ingenus Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208783
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-14-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50742-252). Click a package code to view its specific billing and regulatory data.

50742-252-05
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
50742-252-30
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
50742-252-90
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* 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 50742-252-10 identifies a specific commercial package of 1000 capsule, extended release in 1 bottle of Diltiazem Hydrochloride, a human prescription drug labeled by Ingenus Pharmaceuticals, Llc. This capsule, extended release is formulated for oral 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 Ingenus Pharmaceuticals, Llc on June 14, 2019. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50742025210. 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)
50742-252-10
11-Digit CMS (5-4-2)
50742-0252-10

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