What is NDC 42806-549?

42806-549 is the product NDC for Dutasteride, Dutasteride .5 mg/1 capsule, liquid filled, listed with the FDA by Epic Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Epic Pharma, LLC, NDC labeler code 42806. 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 42806-549 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-549Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0549Add 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
42806-549-09	4280605490942806054909	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-09)Marketed from Nov 28, 2017
42806-549-30	4280605493042806054930	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-30)Marketed from Nov 28, 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: Epic Pharma, LLCNDC labeler code 42806
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 42806-549_2b367985-feb6-bf97-e063-6294a90aede5SPL ID 2b367985-feb6-bf97-e063-6294a90aede5SPL set ID 2ee1eef5-8ec7-46c1-b4fa-13184915448fRxCUI 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

N442806054909 followed by a unit qualifier and the quantity

Package 42806-0549-09. 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 8, 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)

About NDC 42806-549

What is NDC 42806-549?: 42806-549 is the product NDC for Dutasteride, Dutasteride .5 mg/1 capsule, liquid filled, listed with the FDA by Epic Pharma, LLC. It has 2 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?: Epic Pharma, LLC, NDC labeler code 42806. 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	A-S Medication Solutions	50090-7305	50090-7305-0050090-7305-01
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	XLCare Pharmaceuticals, Inc.	72865-140	72865-0140-3072865-0140-90
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.	68071-3757	68071-3757-06
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals, Inc.	68071-3857	68071-3857-09
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
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	Camber Pharmaceuticals, Inc.	31722-131	31722-0131-3031722-0131-90

All 21 Dutasteride NDCs

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	A-S Medication Solutions	50090-7852
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals, Inc.	68071-3757
Dutasteride	Dutasteride .5 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals, Inc.	68071-3857