Bexarotene Capsule, Liquid Filled
NDC Package 43975-315-10

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

Package Information

Bexarotene capsules is bexarotene is used to treat skin problems from a certain type of cancer (cutaneous T-cell lymphoma-CTCL). This formulation utilizes a capsule, liquid filled delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 43975-315 and is authorized under FDA application ANDA209861.

Identification & Billing

NDC Package Code
43975-315-10
Package Description
100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
43975-315
11-Digit Billing Format
43975031510
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 308725 - bexarotene 75 MG Oral Capsule

Clinical Specifications

Proprietary Name
Bexarotene
Non-Proprietary Name
Bexarotene
Substance Name
Bexarotene
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BEXAROTENE 75 mg/1
Pharmacologic Class
Usage Information
Bexarotene is used to treat skin problems from a certain type of cancer (cutaneous T-cell lymphoma-CTCL). It belongs to a class of drugs called retinoids (vitamin A derivatives). Bexarotene works by slowing or stopping the growth of cells.

Regulatory & Marketing

Labeler Name
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209861
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-10-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43975-315-10 identifies a specific commercial package of 100 capsule, liquid filled in 1 bottle of Bexarotene, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This capsule, liquid filled is formulated for oral use and contains bexarotene 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 Ani Pharmaceuticals, Inc. on May 10, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Bexarotene is used to treat skin problems from a certain type of cancer (cutaneous T-cell lymphoma-CTCL). It belongs to a class of drugs called retinoids (vitamin A derivatives). Bexarotene works by slowing or stopping the growth of cells.

How is this Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43975031510. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
43975-315-10
11-Digit CMS (5-4-2)
43975-0315-10

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