Cialis Tablet, Film Coated
NDC Package 0002-4464-30

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

Package Information

Cialis (tadalafil) tablets is tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). This formulation utilizes a tablet, film coated delivery system. Marketed by Eli Lilly And Company, this product is identified by NDC 0002-4464 and is authorized under FDA application NDA021368.

Identification & Billing

NDC Package Code
0002-4464-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0002-4464
11-Digit Billing Format
00002446430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cialis
Non-Proprietary Name
Tadalafil
Substance Name
Tadalafil
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)
TADALAFIL 20 mg/1
Pharmacologic Class
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
Eli Lilly And Company
Product Type
Human Prescription Drug
FDA Application #
NDA021368
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-26-2003
Listing Expiration
12-31-2027
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 0002-4464-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Cialis, a human prescription drug labeled by Eli Lilly And Company. This tablet, film coated is formulated for oral use and contains tadalafil 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 Eli Lilly And Company on November 26, 2003. The current certification is valid through December 31, 2027.

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 Eli Lilly And Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00002446430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0002-4464-30
11-Digit CMS (5-4-2)
00002-4464-30

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