Dexilant Capsule, Delayed Release
NDC Package 64764-175-01

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

Dexilant (dexlansoprazole) capsules is dexlansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). This formulation utilizes a capsule, delayed release delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-175 and is authorized under FDA application NDA022287.

Identification & Billing

NDC Package Code
64764-175-01
Package Description
5 BLISTER PACK in 1 TRAY / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Product Code
64764-175
11-Digit Billing Format
64764017501
RxNorm Crosswalk
  • RxCUI: 833204 - dexlansoprazole 30 MG Delayed Release Oral Capsule
  • RxCUI: 833213 - dexlansoprazole 60 MG Delayed Release Oral Capsule
  • RxCUI: 902624 - Dexilant 30 MG Delayed Release Oral Capsule
  • RxCUI: 902624 - dexlansoprazole 30 MG Delayed Release Oral Capsule [Dexilant]
  • RxCUI: 902626 - Dexilant 60 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Dexilant
Non-Proprietary Name
Dexlansoprazole
Substance Name
Dexlansoprazole
Dosage Form
Capsule, Delayed 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) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXLANSOPRAZOLE 60 mg/1
Pharmacologic Class
Usage Information
Dexlansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Dexlansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022287
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-12-2010
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 (64764-175). Click a package code to view its specific billing and regulatory data.

64764-175-00
7 CAPSULE, DELAYED RELEASE in 1 BOTTLE
64764-175-02
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
64764-175-11
10 BLISTER PACK in 1 CARTON / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
64764-175-19
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE
64764-175-30
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
64764-175-90
90 CAPSULE, DELAYED 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 64764-175-01 identifies a specific commercial package of 5 blister pack in 1 tray / 4 capsule, delayed release in 1 blister pack of Dexilant, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This capsule, delayed release is formulated for oral use and contains dexlansoprazole 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 Takeda Pharmaceuticals America, Inc. on April 12, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Dexlansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Dexlansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64764017501. 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)
64764-175-01
11-Digit CMS (5-4-2)
64764-0175-01

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