Dutasteride NDC 65162-750

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-750Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0750Add 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
65162-750-03	65162075003	30 CAPSULE in 1 BOTTLE (65162-750-03)Marketed from Nov 2, 2015
65162-750-09	65162075009	90 CAPSULE in 1 BOTTLE (65162-750-09)Marketed from Nov 2, 2015

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: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203118
Marketing start: Nov 2, 2015
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 65162-750_d1ac003d-2e58-4a30-8072-8419e7ebb4c6SPL ID d1ac003d-2e58-4a30-8072-8419e7ebb4c6SPL set ID e537c60d-9ba2-4e7f-a405-2b915dcd7eadRxCUI 351172UNII O0J6XJN02IUPC 0365162750096, 0365162750034
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

N465162075003 followed by a unit qualifier and the quantity

Package 65162-0750-03. 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 24, 2023.

Indications (excerpt from the label)

Dutasteride capsules 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 capsules in combination with the alpha-adrenergic antagonist, tamsulosin, are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203118

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

FDA NDC Directory listings under ANDA 203118
Product	Strength	Form · route	Labeler	Product NDC
Dutasteride	Dutasteride .5 mg/1	CapsuleOral	Proficient Rx LP	71205-039