Finasteride NDC 0615-8562

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8562Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8562Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0615-8562-05	00615856205	15 TABLET in 1 BLISTER PACK (0615-8562-05)Marketed from Feb 11, 2025
0615-8562-39	00615856239	30 TABLET in 1 BLISTER PACK (0615-8562-39)Marketed from Feb 11, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Finasteride
Generic name (nonproprietary): finasteride
Active ingredients: Finasteride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076437
Marketing start: Feb 28, 2007
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 0615-8562_4e1dfb0e-d523-48d2-8c82-c80ee2b49800SPL ID 4e1dfb0e-d523-48d2-8c82-c80ee2b49800SPL set ID 8c3b1f6b-0010-4432-8eda-4af3c3573063RxCUI 310346UNII 57GNO57U7G
Pharmacologic class: 5-alpha Reductase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400615856205 followed by a unit qualifier and the quantity

Package 00615-8562-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 19, 2025.

Indications (excerpt from the label)

Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2). Limitations of Use : Finasteride is not approved for the prevention of prostate cancer (1.3). 1.1 Monotherapy Finasteride tablet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076437

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076437
Product	Strength	Form · route	Labeler	Product NDC
Finasteride	Finasteride 5 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-172