Finasteride Tablet, Coated
NDC Package 70518-2287-2

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

Package Information

Finasteride tablets is finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. This formulation utilizes a tablet, coated delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-2287 and is authorized under FDA application ANDA207750.

Identification & Billing

NDC Package Code
70518-2287-2
Package Description
30 TABLET, COATED in 1 BLISTER PACK
Product Code
70518-2287
11-Digit Billing Format
70518228702
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Finasteride
Non-Proprietary Name
Finasteride
Substance Name
Finasteride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FINASTERIDE 1 mg/1
Pharmacologic Class
Usage Information
Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. It may be used alone or taken in combination with other medications to reduce symptoms of BPH and may also reduce the need for surgery. Finasteride may improve symptoms of BPH and provide benefits such as decreased urge to urinate, better urine flow with less straining, less of a feeling that the bladder is not completely emptied, and decreased nighttime urination. This medication works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate. Finasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. Women and children should not use this medication.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207750
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-27-2019
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 (70518-2287). Click a package code to view its specific billing and regulatory data.

70518-2287-0
90 TABLET, COATED in 1 BOTTLE, PLASTIC
70518-2287-1
30 TABLET, COATED in 1 BOTTLE, PLASTIC
70518-2287-3
12 TABLET, COATED in 1 BOTTLE, PLASTIC
70518-2287-4
30 POUCH in 1 BOX / 1 TABLET, COATED in 1 POUCH (70518-2287-5)

* 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 70518-2287-2 identifies a specific commercial package of 30 tablet, coated in 1 blister pack of Finasteride, a human prescription drug labeled by Remedyrepack Inc.. This tablet, 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 Remedyrepack Inc. on August 27, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. It may be used alone or taken in combination with other medications to reduce symptoms of BPH and may also reduce the need for surgery. Finasteride may improve symptoms of BPH and provide benefits such as decreased urge to urinate, better urine flow with less straining, less of a feeling that the bladder is not completely emptied, and decreased nighttime urination. This medication works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate. Finasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. Women and children should not use this medication.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518228702. 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 (5-4-1)
70518-2287-2
11-Digit CMS (5-4-2)
70518-2287-02

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