Prevacid Solutab Tablet, Orally Disintegrating, Delayed Release
NDC Package 64764-543-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Prevacid Solutab (lansoprazole) tablets is lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a tablet, orally disintegrating, delayed release delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-543 and is authorized under FDA application NDA021428.

Identification & Billing

NDC Package Code
64764-543-05
Package Description
5 BLISTER PACK in 1 TRAY / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Product Code
11-Digit Billing Format
64764054305
RxNorm Crosswalk
  • RxCUI: 206205 - Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral Tablet
  • RxCUI: 206205 - lansoprazole 15 MG Disintegrating Oral Tablet [Prevacid]
  • RxCUI: 206205 - Prevacid 15 MG Delayed Release Disintegrating Oral Tablet
  • RxCUI: 206206 - Prevacid 30 MG Delayed Release Oral Capsule
  • RxCUI: 206206 - lansoprazole 30 MG Delayed Release Oral Capsule [Prevacid]

Clinical Specifications

Proprietary Name
Prevacid Solutab
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)
Usage Information
Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). 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. Lansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter lansoprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021428
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-30-2002
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 (64764-543). Click a package code to view its specific billing and regulatory data.

10 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (64764-543-30)

* 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 64764-543-05 identifies a specific commercial package of 5 blister pack in 1 tray / 3 tablet, orally disintegrating, delayed release in 1 blister pack of Prevacid Solutab, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. 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 Takeda Pharmaceuticals America, Inc. on August 30, 2002. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). 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. Lansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter lansoprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

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: 64764054305. 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)
64764-543-05
11-Digit CMS (5-4-2)
64764-0543-05

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