What is NDC 59651-063?

59651-063 is the product NDC for Dutasteride and Tamsulosin Hydrochloride, Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Dutasteride, Tamsulosin hydrochloride.

Aurobindo Pharma Limited, NDC labeler code 59651. 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 and Tamsulosin Hydrochloride?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dutasteride and Tamsulosin Hydrochloride NDC 59651-063

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-063Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0063Add 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
59651-063-30	59651006330	30 CAPSULE in 1 BOTTLE (59651-063-30)Marketed from Jul 18, 2024
59651-063-90	59651006390	90 CAPSULE in 1 BOTTLE (59651-063-90)Marketed from Jul 18, 2024

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 and Tamsulosin Hydrochloride
Generic name (nonproprietary): dutasteride and tamsulosin hydrochloride
Active ingredients: Dutasteride — .5 mg/1Tamsulosin hydrochloride — .4 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213300
Marketing start: Jul 18, 2024
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 59651-063_2ad47033-76f3-447d-8a44-21479e9164c0SPL ID 2ad47033-76f3-447d-8a44-21479e9164c0SPL set ID 2ad47033-76f3-447d-8a44-21479e9164c0RxCUI 996097UNII O0J6XJN02I, 11SV1951MRUPC 0359651063903
Pharmacologic class: 5-alpha Reductase Inhibitor; alpha-Adrenergic Blocker

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

N459651006330 followed by a unit qualifier and the quantity

Package 59651-0063-30. 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 Jul 19, 2024.

Indications (excerpt from the label)

Dutasteride and tamsulosin hydrochloride capsules are a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-063

What is NDC 59651-063?: 59651-063 is the product NDC for Dutasteride and Tamsulosin Hydrochloride, Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dutasteride and Tamsulosin Hydrochloride.
What is the active ingredient?: Dutasteride, Tamsulosin hydrochloride.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 59651. 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 and Tamsulosin Hydrochloride?: 2 other product NDCs are listed under this name. See all Dutasteride and Tamsulosin Hydrochloride 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 and Tamsulosin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dutasteride and tamsulosin hydrochloride	Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	68382-640	68382-0640-0668382-0640-16
Dutasteride and tamsulosin hydrochloride	Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1356	70771-1356-0370771-1356-09