Samsca Tablet
NDC Package 59148-021-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Samsca (tolvaptan) tablets is a medication used to treat low levels of salt (sodium) in the blood, which can result from conditions such as heart failure and certain hormone imbalances. This formulation utilizes a tablet delivery system. Marketed by Otsuka America Pharmaceutical, Inc., this product is identified by NDC 59148-021 and is authorized under FDA application NDA022275.

Identification & Billing

NDC Package Code
59148-021-50
Package Description
1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
59148-021
11-Digit Billing Format
59148002150
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Samsca
Non-Proprietary Name
Tolvaptan
Substance Name
Tolvaptan
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOLVAPTAN 30 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat low levels of salt (sodium) in the blood, which can result from conditions such as heart failure and certain hormone imbalances. Tolvaptan belongs to a class of drugs known as vasopressin receptor antagonists. It works by increasing the amount of urine you make, causing your body to get rid of extra water. This helps to slowly increase to normal levels of salt in the blood. Different brands of this medication have different uses. Do not change brands of this medication unless directed by your doctor.

Regulatory & Marketing

Labeler Name
Otsuka America Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022275
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-19-2009
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 59148-021-50 identifies a specific commercial package of 1 blister pack in 1 carton / 10 tablet in 1 blister pack of Samsca, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for oral use and contains tolvaptan 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 Otsuka America Pharmaceutical, Inc. on May 19, 2009. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat low levels of salt (sodium) in the blood, which can result from conditions such as heart failure and certain hormone imbalances. Tolvaptan belongs to a class of drugs known as vasopressin receptor antagonists. It works by increasing the amount of urine you make, causing your body to get rid of extra water. This helps to slowly increase to normal levels of salt in the blood. Different brands of this medication have different uses. Do not change brands of this medication unless directed by your doctor.

How is this Otsuka America Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59148002150. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
59148-021-50
11-Digit CMS (5-4-2)
59148-0021-50

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