Dexlansoprazole Capsule, Delayed Release Pellets
NDC Package 0378-2086-77

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

Dexlansoprazole capsules is dexlansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). This formulation utilizes a capsule, delayed release pellets delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-2086 and is authorized under FDA application ANDA205205.

Identification & Billing

NDC Package Code
0378-2086-77
Package Description
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC
Product Code
0378-2086
11-Digit Billing Format
00378208677
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
  • RxCUI: 833204 - dexlansoprazole 30 MG Delayed Release Oral Capsule
  • RxCUI: 833213 - dexlansoprazole 60 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Dexlansoprazole
Non-Proprietary Name
Dexlansoprazole
Substance Name
Dexlansoprazole Sesquihydrate
Dosage Form
Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXLANSOPRAZOLE SESQUIHYDRATE 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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205205
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-22-2024
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 (0378-2086). Click a package code to view its specific billing and regulatory data.

0378-2086-93
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC

* 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 0378-2086-77 identifies a specific commercial package of 90 capsule, delayed release pellets in 1 bottle, plastic of Dexlansoprazole, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This capsule, delayed release pellets is formulated for oral use and contains dexlansoprazole sesquihydrate 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 Mylan Pharmaceuticals Inc. on January 22, 2024. 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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378208677. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
0378-2086-77
11-Digit CMS (5-4-2)
00378-2086-77

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