Levitra
NDC Package 43353-741-52
Package Information
Levitra is vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). Marketed by Aphena Pharma Solutions - Tennessee, Inc., this product is identified by NDC 43353-741 and is authorized under FDA application NDA021400.
Identification & Billing
- RxCUI: 349478 - vardenafil 5 MG Oral Tablet
- RxCUI: 349478 - vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral Tablet
- RxCUI: 349479 - vardenafil HCl 10 MG Oral Tablet
- RxCUI: 349479 - vardenafil 10 MG Oral Tablet
- RxCUI: 349479 - vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 43353 - Aphena Pharma Solutions - Tennessee, Inc.
- 43353-741 - Levitra
- 43353-741-52 - 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- 43353-741 - Levitra
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 (43353-741). Click a package code to view its specific billing and regulatory data.
* 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 43353-741-52 identifies a specific commercial package of 18 tablet, film coated in 1 bottle, plastic of Levitra, labeled by Aphena Pharma Solutions - Tennessee, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 18 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Inc. on April 22, 2011. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
Vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.
How is this Aphena Pharma Solutions - Tennessee, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353074152. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 18 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
