Dutasteride NDC 68071-3757

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3757Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3757Add 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
68071-3757-6	68071375706	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-3757-6)Marketed from Jan 3, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: NuCare Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209909
Marketing start: Nov 28, 2017
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 68071-3757_2ad2f521-f578-01c4-e063-6394a90ac831SPL ID 2ad2f521-f578-01c4-e063-6394a90ac831SPL set ID 2ad309b1-4497-8b9b-e063-6394a90aa9b4RxCUI 351172UNII O0J6XJN02IUPC 0368071375763
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

N468071375706 followed by a unit qualifier and the quantity

Package 68071-3757-06. 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 Jan 3, 2025.

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, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2) Limitations of Use: Dutasteride capsules 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209909

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

FDA NDC Directory listings under ANDA 209909
Product	Strength	Form · route	Labeler	Product NDC
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals, Inc.	68071-3857
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Epic Pharma, LLC	42806-549
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	A-S Medication Solutions	50090-7852