What is NDC 82009-061?

82009-061 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by QUALLENT PHARMACEUTICALS HEALTH LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

QUALLENT PHARMACEUTICALS HEALTH LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Finasteride?

68 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Finasteride NDC 82009-061 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82009-061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82009-0061Add 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
82009-061-05	8200900610582009006105	500 TABLET, FILM COATED in 1 BOTTLE (82009-061-05)Marketed from Nov 21, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Film coated
Route: Oral
Labeler: QUALLENT PHARMACEUTICALS HEALTH LLCNDC labeler code 82009
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078341
Marketing start: Nov 21, 2022
Listing expires: Dec 31, 2027
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 82009-061_109360b9-d88b-4754-99ba-a189cd9eca88SPL ID 109360b9-d88b-4754-99ba-a189cd9eca88SPL set ID 5efc695c-d9fd-4892-a63f-a35cceb8d3c7RxCUI 310346UNII 57GNO57U7GUPC 0382009061054
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

N482009006105 followed by a unit qualifier and the quantity

Package 82009-0061-05. 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 Aug 20, 2026.

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 tablets administered in combination with the alpha-blocker doxazosin are 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 tablets are not approved for the prevention of prostate cancer (1.3) . 1.1 Monotherap…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82009-061

What is NDC 82009-061?: 82009-061 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by QUALLENT PHARMACEUTICALS HEALTH LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Finasteride.
What is the active ingredient?: Finasteride.
Who is the labeler?: QUALLENT PHARMACEUTICALS HEALTH LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Finasteride?: 68 other product NDCs are listed under this name. See all Finasteride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Finasteride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Finasteride	Finasteride 1 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4687	70518-4687-00
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1058	67046-1058-03
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2639	55154-2639-00
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8749	68788-8749-0168788-8749-0368788-8749-06+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8433	68788-8433-0168788-8433-0368788-8433-06+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-542	72189-0542-3072189-0542-90
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8377	68788-8377-0168788-8377-0368788-8377-06+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3616	70518-3616-0170518-3616-0370518-3616-04+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3600	70518-3600-0170518-3600-0370518-3600-04
Finasteride	Finasteride 1 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-714	47335-0714-0847335-0714-1847335-0714-81+2 more

All 69 Finasteride NDCs

Other NDCs under ANDA 078341

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

FDA NDC Directory listings under ANDA 078341
Product	Strength	Form · route	Labeler	Product NDC
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6940
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6941
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-062
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-428
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-1585
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1058
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3234
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3417
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3785
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8749
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1704
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3616
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1530
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-154