Cialis
NDC Package 43353-044-18

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cialis is tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-044 and is authorized under FDA application NDA021368.

Identification & Billing

NDC Package Code
43353-044-18
Package Description
16 TABLET, FILM COATED in 1 BOTTLE
Product Code
11-Digit Billing Format
43353004418
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
16 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cialis
Dosage Form
-
Usage Information
Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection. Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder. 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.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
NDA021368
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-26-2003
Listing Expiration
12-31-2022
Exclude Flag
I
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 (43353-044). Click a package code to view its specific billing and regulatory data.

4 TABLET, FILM COATED in 1 BOTTLE
8 TABLET, FILM COATED in 1 BOTTLE
48 TABLET, FILM COATED in 1 BOTTLE
24 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 43353-044-18 identifies a specific commercial package of 16 tablet, film coated in 1 bottle of Cialis, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 16 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, Llc on November 26, 2003. The current certification is valid through December 31, 2022.

What are the primary indications for this medication?

Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection. Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder. 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, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353004418. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 16 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)
43353-044-18
11-Digit CMS (5-4-2)
43353-0044-18

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