Lansoprazole Tablet, Orally Disintegrating, Delayed Release
NDC Package 55154-8340-0

11-digit billing NDC: 55154834000
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lansoprazole tablets is •Lansoprazole delayed-release orally disintegrating tablets are contraindicated in patients with known hypersensitivity to any component of the formulation. This formulation utilizes a tablet, orally disintegrating, delayed release delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-8340 and is authorized under FDA application ANDA207167.

Identification & Billing

NDC Package Code
55154-8340-0
Package Description
1 BLISTER PACK in 1 BAG / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Product Code
55154-8340
11-Digit Billing Format
55154834000
RxNorm Crosswalk
  • RxCUI: 351260 - lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet
  • RxCUI: 351260 - lansoprazole 30 MG Disintegrating Oral Tablet

Clinical Specifications

Proprietary Name
Lansoprazole
Non-Proprietary Name
Lansoprazole
Substance Name
Lansoprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LANSOPRAZOLE 30 mg/1
Pharmacologic Class
Usage Information
•Lansoprazole delayed-release orally disintegrating tablets are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)].• Proton Pump Inhibitors (PPIs), including  lansoprazole delayed-release orally disintegrating tablets, are contraindicated with rilpivirine-containing products [see Drug Interactions  (7)].•For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release orally disintegrating tablets, refer to the Contraindications section of their prescribing information.

Regulatory & Marketing

Labeler Name
Cardinal Health 107, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207167
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-24-2026
Listing Expiration
12-31-2027
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 55154-8340-0 identifies a specific commercial package of 1 blister pack in 1 bag / 10 tablet, orally disintegrating, delayed release in 1 blister pack of Lansoprazole, a human prescription drug labeled by Cardinal Health 107, Llc. This tablet, orally disintegrating, delayed release is formulated for oral use and contains lansoprazole 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 Cardinal Health 107, Llc on August 24, 2026. The current certification is valid through December 31, 2027.

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154834000. 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 (5-4-1)
55154-8340-0
11-Digit CMS (5-4-2)
55154-8340-00

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