Lansoprazole Capsule, Delayed Release
NDC Package 33342-310-07

11-digit billing NDC: 33342031007
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lansoprazole capsules is lansoprazole delayed-release capsules are contraindicated in patients with known severe hypersensitivity to any component of the formulation. This formulation utilizes a capsule, delayed release delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-310 and is authorized under FDA application ANDA208671.

Identification & Billing

NDC Package Code
33342-310-07
Package Description
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
33342-310
11-Digit Billing Format
33342031007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lansoprazole
Non-Proprietary Name
Lansoprazole
Substance Name
Lansoprazole
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)
LANSOPRAZOLE 15 mg/1
Pharmacologic Class
Usage Information
Lansoprazole delayed-release capsules are contraindicated in patients with known severe 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 is 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 capsules, refer to the Contraindications section of their prescribing information.

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA208671
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-05-2024
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 33342-310-07 identifies a specific commercial package of 30 capsule, delayed release in 1 bottle of Lansoprazole, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This capsule, 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 Macleods Pharmaceuticals Limited on November 05, 2024. The current certification is valid through December 31, 2027.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342031007. 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)
33342-310-07
11-Digit CMS (5-4-2)
33342-0310-07

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