Tolvaptan Tablet
NDC Package 72603-932-01

11-digit billing NDC: 72603093201 · Billing unit: EA · 10 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).Limitations of Use  Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. This formulation utilizes a tablet delivery system. Marketed by Northstar Rx Llc, this product is identified by NDC 72603-932 and is authorized under FDA application ANDA216949.

Identification & Billing

NDC Package Code
72603-932-01
Package Description
1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
72603-932
11-Digit Billing Format
72603093201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tolvaptan
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 15 mg/1
Pharmacologic Class
Usage Information
Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).Limitations of Use  Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets.  It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.

Regulatory & Marketing

Labeler Name
Northstar Rx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216949
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-21-2023
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 72603-932-01 identifies a specific commercial package of 1 blister pack in 1 carton / 10 tablet in 1 blister pack of Tolvaptan, a human prescription drug labeled by Northstar Rx Llc. 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 Northstar Rx Llc on June 21, 2023. The current certification is valid through December 31, 2027.

How is this Northstar Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72603093201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
72603-932-01
11-Digit CMS (5-4-2)
72603-0932-01

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