Ambrisentan Tablet, Film Coated
NDC Package 47335-237-64

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

Package Information

Ambrisentan tablets is ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This formulation utilizes a tablet, film coated delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-237 and is authorized under FDA application ANDA210784.

Identification & Billing

NDC Package Code
47335-237-64
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60)
Product Code
47335-237
11-Digit Billing Format
47335023764
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ambrisentan
Non-Proprietary Name
Ambrisentan
Substance Name
Ambrisentan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMBRISENTAN 10 mg/1
Pharmacologic Class
Usage Information
Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms, and improve your ability to exercise.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210784
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-29-2019
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 (47335-237). Click a package code to view its specific billing and regulatory data.

47335-237-66
1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60)
47335-237-83
30 TABLET, FILM COATED in 1 BOTTLE
47335-237-85
10 TABLET, FILM COATED in 1 BOTTLE

* 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 47335-237-64 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack (47335-237-60) of Ambrisentan, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, film coated is formulated for oral use and contains ambrisentan 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 Sun Pharmaceutical Industries, Inc. on April 29, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms, and improve your ability to exercise.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335023764. 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)
47335-237-64
11-Digit CMS (5-4-2)
47335-0237-64

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