What is NDC 71205-278?

71205-278 is the product NDC for Dutasteride, Dutasteride .5 mg/1 capsule, liquid filled, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dutasteride?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dutasteride NDC 71205-278 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0278Add 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
71205-278-30	71205027830	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-30)Marketed from May 1, 2019
71205-278-60	71205027860	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-60)Marketed from May 1, 2019
71205-278-90	71205027890	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-90)Marketed from May 1, 2019

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: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206574
Marketing start: Oct 24, 2016
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71205-278_85ae04d1-a76d-49b9-bb46-8dd37e7881a1SPL ID 85ae04d1-a76d-49b9-bb46-8dd37e7881a1SPL set ID 908832b2-21d6-48ae-89cb-f06687321f74RxCUI 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

N471205027830 followed by a unit qualifier and the quantity

Package 71205-0278-30. 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 Oct 1, 2024.

Indications (excerpt from the label)

Dutasteride 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 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 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 with an enlarged …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-278

What is NDC 71205-278?: 71205-278 is the product NDC for Dutasteride, Dutasteride .5 mg/1 capsule, liquid filled, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dutasteride.
What is the active ingredient?: Dutasteride.
Who is the labeler?: Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dutasteride?: 20 other product NDCs are listed under this name. See all Dutasteride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dutasteride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dutasteride	Dutasteride .5 mg/1	CapsuleOral	Banyan Pharma LLC	84091-100	84091-0100-90
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Aurobindo Pharma Limited	59651-021	59651-0021-3059651-0021-90
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	A-S Medication Solutions	50090-7305	50090-7305-0050090-7305-01
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	XLCare Pharmaceuticals, Inc.	72865-140	72865-0140-3072865-0140-90
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals, Inc.	68071-3757	68071-3757-06
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	A-S Medication Solutions	50090-7852	50090-7852-0050090-7852-01
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals, Inc.	68071-3857	68071-3857-09
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Epic Pharma, LLC	42806-549	42806-0549-0942806-0549-30
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	MARKSANS PHARMA LIMITED	25000-011	25000-0011-0325000-0011-0725000-0011-27
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Strides Pharma Science Limited	64380-763	64380-0763-0464380-0763-05

All 21 Dutasteride NDCs

Other NDCs under ANDA 206574

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

FDA NDC Directory listings under ANDA 206574
Product	Strength	Form · route	Labeler	Product NDC
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Camber Pharmaceuticals, Inc.	31722-131
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	A-S Medication Solutions	50090-4010
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	63629-1222
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	63629-1223
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	63629-8207
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals, Inc.	68071-3732
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals,Inc.	68071-4821
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	72162-1296
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	XLCare Pharmaceuticals, Inc.	72865-140