Dutasteride NDC 59651-021

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0021Add 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
59651-021-30	59651002130	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-30)Marketed from Jan 20, 2023
59651-021-90	59651002190	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-90)Marketed from Jan 20, 2023

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, Liquid filled
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202660
Marketing start: Jan 20, 2023
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 59651-021_cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3SPL ID cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3SPL set ID b32611f3-50ec-45bb-a671-ea10cec7829dRxCUI 351172UNII O0J6XJN02IUPC 0359651021309
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

N459651002130 followed by a unit qualifier and the quantity

Package 59651-0021-30. 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 Sep 11, 2025.

Indications (excerpt from the label)

Dutasteride capsules are 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 capsules are 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 wit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202660

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

FDA NDC Directory listings under ANDA 202660
Product	Strength	Form · route	Labeler	Product NDC
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	A-S Medication Solutions	50090-7305