Finasteride Tablet, Film Coated
NDC Package 76420-154-90

11-digit billing NDC: 76420015490
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Finasteride tablets are contraindicated in the following:Hypersensitivity to any component of this medication.Pregnancy. This formulation utilizes a tablet, film coated delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-154 and is authorized under FDA application ANDA078341.

Identification & Billing

NDC Package Code
76420-154-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
76420-154
11-Digit Billing Format
76420015490
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Finasteride
Non-Proprietary Name
Finasteride
Substance Name
Finasteride
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)
FINASTERIDE 5 mg/1
Pharmacologic Class
Usage Information
Finasteride tablets are contraindicated in the following:Hypersensitivity to any component of this medication.Pregnancy. Finasteride use is contraindicated in females when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant female who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3), Use in Specific Populations (8.1), and How Supplied/Storage and Handling (16).] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078341
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-30-2007
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76420-154). Click a package code to view its specific billing and regulatory data.

76420-154-30
30 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 76420-154-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Finasteride, a human prescription drug labeled by Asclemed Usa, Inc.. This tablet, film coated is formulated for oral use and contains finasteride 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 Asclemed Usa, Inc. on October 30, 2007. The current certification is valid through December 31, 2027.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420015490. 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)
76420-154-90
11-Digit CMS (5-4-2)
76420-0154-90

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