What is NDC 80725-809?

80725-809 is the product NDC for Jalyn, Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Waylis Therapeutics. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Dutasteride, Tamsulosin hydrochloride.

Waylis Therapeutics, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Jalyn?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Jalyn NDC 80725-809 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80725-809Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80725-0809Add 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
80725-809-13	80725080913	30 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-13)Marketed from Mar 1, 2024
80725-809-59	80725080959	90 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-59)Marketed from Mar 1, 2024

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): Jalyn
Generic name (nonproprietary): dutasteride and tamsulosin hydrochloride
Active ingredients: Dutasteride — .5 mg/1Tamsulosin hydrochloride — .4 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Waylis TherapeuticsNDC labeler code 80725
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022460
Marketing start: Mar 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 80725-809_bc6c62ea-da7b-4c27-a88e-c80cfcd7856dSPL ID bc6c62ea-da7b-4c27-a88e-c80cfcd7856dSPL set ID aab9a2d4-5328-40f3-986f-e7753a928bc0RxCUI 996097, 996101UNII O0J6XJN02I, 11SV1951MR
Pharmacologic class: 5-alpha Reductase Inhibitor; alpha-Adrenergic Blocker

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

N480725080913 followed by a unit qualifier and the quantity

Package 80725-0809-13. 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 Mar 9, 2026.

Indications (excerpt from the label)

JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80725-809

What is NDC 80725-809?: 80725-809 is the product NDC for Jalyn, Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Waylis Therapeutics. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Jalyn (DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE).
What is the active ingredient?: Dutasteride, Tamsulosin hydrochloride.
Who is the labeler?: Waylis Therapeutics, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Jalyn?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Jalyn (Dutasteride and tamsulosin hydrochloride) NDC 80725-809