Bosentan Tablet, For Suspension
NDC Package 70710-1508-8

11-digit billing NDC: 70710150808 · Billing unit: EA · 56 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bosentan tablets is for oral suspension are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):in adults to improve exercise ability and to decrease clinical worsening. This formulation utilizes a tablet, for suspension delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1508 and is authorized under FDA application ANDA213981.

Identification & Billing

NDC Package Code
70710-1508-8
Package Description
4 BLISTER PACK in 1 CARTON / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70710-1508-7)
Product Code
70710-1508
11-Digit Billing Format
70710150808
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
56 EA
RxNorm Crosswalk
RxCUI: 1989081 - bosentan 32 MG Tablet for Oral Suspension

Clinical Specifications

Proprietary Name
Bosentan
Non-Proprietary Name
Bosentan
Substance Name
Bosentan
Dosage Form
Tablet, For Suspension - A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BOSENTAN 32 mg/1
Pharmacologic Class
Usage Information
Bosentan tablets for oral suspension are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%) and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)] .in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213981
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-17-2026
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 70710-1508-8 identifies a specific commercial package of 4 blister pack in 1 carton / 14 tablet, for suspension in 1 blister pack (70710-1508-7) of Bosentan, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 56 billable units per package. This tablet, for suspension is formulated for oral use and contains bosentan 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 Zydus Pharmaceuticals Usa Inc. on February 17, 2026. The current certification is valid through December 31, 2027.

How is this Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710150808. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 56 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 (5-4-1)
70710-1508-8
11-Digit CMS (5-4-2)
70710-1508-08

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