Dutasteride and tamsulosin hydrochloride NDC 68382-640

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-640Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0640Add 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
68382-640-06	68382064006	30 CAPSULE in 1 BOTTLE (68382-640-06)Marketed from Jun 4, 2018
68382-640-16	68382064016	90 CAPSULE in 1 BOTTLE (68382-640-16)Marketed from Jun 4, 2018

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: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207769
Marketing start: Jun 4, 2018
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 68382-640_9e44a416-1d3d-418c-a113-f6c65175b564SPL ID 9e44a416-1d3d-418c-a113-f6c65175b564SPL set ID d6557691-7910-4006-9268-410583e437d1RxCUI 996097UNII O0J6XJN02I, 11SV1951MR
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

N468382064006 followed by a unit qualifier and the quantity

Package 68382-0640-06. 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 Nov 11, 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)

Other NDCs under ANDA 207769

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

FDA NDC Directory listings under ANDA 207769
Product	Strength	Form · route	Labeler	Product NDC
Dutasteride and tamsulosin hydrochloride	Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1356