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  5. NDC Package Code: 68382-595-01 Diltiazem Hydrochloride

NDC Package 68382-595-01 Diltiazem Hydrochloride

Capsule, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68382-595-01
Package Description:
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
68382-595
Proprietary Name:
Diltiazem Hydrochloride
Non-Proprietary Name:
Diltiazem Hydrochloride
Substance Name:
Diltiazem Hydrochloride
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.
11-Digit NDC Billing Format:
68382059501
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals (usa) Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DILTIAZEM HYDROCHLORIDE 120 mg/1
    • Pharmacologic Class(es):
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA206534
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-28-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68382-595-05500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
    68382-595-0630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
    68382-595-1690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
    68382-595-7710 BLISTER PACK in 1 CARTON / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-595-30)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68382-595-01?

    The NDC Packaged Code 68382-595-01 is assigned to a package of 100 capsule, extended release in 1 bottle of Diltiazem Hydrochloride, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 68382-595 included in the NDC Directory?

    Yes, Diltiazem Hydrochloride with product code 68382-595 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals (usa) Inc. on September 28, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68382-595-01?

    The 11-digit format is 68382059501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268382-595-015-4-268382-0595-01