Dutasteride NDC 25000-011

NDC codes

FDA NDC Directory

Product NDC (as listed)25000-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25000-0011Add 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
25000-011-03	25000001103	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03)Marketed from Apr 27, 2017
25000-011-07	25000001107	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07)Marketed from Apr 27, 2017
25000-011-27	25000001127	4 BAG in 1 BOX (25000-011-27) / 2500 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Apr 27, 2017

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: MARKSANS PHARMA LIMITED
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204376
Marketing start: Apr 27, 2017
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 25000-011_85bb4dcb-29f9-4490-b88a-725183e258e7SPL ID 85bb4dcb-29f9-4490-b88a-725183e258e7SPL set ID c4bc56a1-e31c-44fb-bfb5-f77425ff1ea1RxCUI 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

N425000001103 followed by a unit qualifier and the quantity

Package 25000-0011-03. 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 Jul 22, 2024.

Indications (excerpt from the label)

1.1 Monotherapy Dutasteride Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: · improve symptoms, · reduce the risk of acute urinary retention (AUR), and · reduce the risk of the need for BPH-related surgery. 1.2 Combination with Alpha-adrenergic Antagonist Dutasteride Capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.3 Limitations of Use Dutasteride Capsules are not approved for the prevention of prostate cancer. Dutasteride Capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptoma…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)