Dutasteride NDC 84091-100

NDC codes

FDA NDC Directory

Product NDC (as listed)84091-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84091-0100Add 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
84091-100-90	84091010090	90 CAPSULE in 1 BOTTLE (84091-100-90)Marketed from Dec 31, 2025

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): Dutasteride
Generic name (nonproprietary): dutasteride
Active ingredients: Dutasteride — .5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Banyan Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204705
Marketing start: Dec 31, 2025
Listing expires: Dec 31, 2027
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 84091-100_aff70ad7-652a-496f-b351-58c3ebd446e9SPL ID aff70ad7-652a-496f-b351-58c3ebd446e9SPL set ID 947644ea-bc35-41df-8a7a-874360c90192RxCUI 351172UNII O0J6XJN02I
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

N484091010090 followed by a unit qualifier and the quantity

Package 84091-0100-90. 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 Jul 29, 2026.

Indications (excerpt from the label)

Dutasteride is a 5 alpha-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, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. ( 1.2 ) Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. ( 1.3 ) 1.1 Monotherapy Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prosta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)