Finasteride
NDC Package 51079-321-56
Package Information
Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. Marketed by Mylan Institutional Inc., this product is identified by NDC 51079-321 and is authorized under FDA application ANDA077578.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 51079 - Mylan Institutional Inc.
- 51079-321 - Finasteride
- 51079-321-56 - 10 DOSE PACK in 1 CARTON / 30 BLISTER PACK in 1 DOSE PACK (51079-321-30) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-321-01)
- 51079-321 - Finasteride
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 (51079-321). 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 51079-321-56 identifies a specific commercial package of 10 dose pack in 1 carton / 30 blister pack in 1 dose pack (51079-321-30) / 1 tablet, film coated in 1 blister pack (51079-321-01) of Finasteride, labeled by Mylan Institutional Inc.. 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 Mylan Institutional Inc. on July 13, 2015. The current certification is valid through June 30, 2019.
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 Mylan Institutional Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 51079032156. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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.