Vardenafil Tablet, Orally Disintegrating
NDC Package 46708-235-04

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

Package Information

Vardenafil tablets is vardenafil hydrochloride orally disintegrating tablets are indicated for the treatment of erectile dysfunction. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-235 and is authorized under FDA application ANDA208324.

Identification & Billing

NDC Package Code
46708-235-04
Package Description
4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
46708-235
11-Digit Billing Format
46708023504
RxNorm Crosswalk
  • RxCUI: 996179 - vardenafil 10 MG Disintegrating Oral Tablet
  • RxCUI: 996179 - vardenafil 10 MG (vardenafil HCl 11.85 MG) Disintegrating Oral Tablet

Clinical Specifications

Proprietary Name
Vardenafil
Non-Proprietary Name
Vardenafil
Substance Name
Vardenafil Hydrochloride Trihydrate
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VARDENAFIL HYDROCHLORIDE TRIHYDRATE 10 mg/1
Pharmacologic Class
Usage Information
Vardenafil hydrochloride orally disintegrating tablets are indicated for the treatment of erectile dysfunction.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA208324
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2018
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 46708-235-04 identifies a specific commercial package of 4 tablet, orally disintegrating in 1 blister pack of Vardenafil, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet, orally disintegrating is formulated for oral use and contains vardenafil hydrochloride trihydrate 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 Alembic Pharmaceuticals Limited on November 20, 2018. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708023504. 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)
46708-235-04
11-Digit CMS (5-4-2)
46708-0235-04

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