Dutasteride NDC 50090-7305

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-7305Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-7305Add 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
50090-7305-0	50090730500	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7305-0)Marketed from Oct 14, 2024
50090-7305-1	50090730501	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7305-1)Marketed from Oct 14, 2024

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: A-S Medication Solutions
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 50090-7305_c9fdff9e-14e3-4d2a-80d2-8c93ed67b459SPL ID c9fdff9e-14e3-4d2a-80d2-8c93ed67b459SPL set ID 468df1b8-1f82-4328-a549-0a716ad1266dRxCUI 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

N450090730500 followed by a unit qualifier and the quantity

Package 50090-7305-00. 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 Oct 21, 2024.

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	Aurobindo Pharma Limited	59651-021