Alfuzosin hydrochloride NDC 76282-302

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-302Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0302Add 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
76282-302-01	76282030201	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01)Marketed from Oct 2, 2012
76282-302-05	76282030205	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05)Marketed from Oct 2, 2012
76282-302-10	76282030210	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10)Marketed from Oct 2, 2012
76282-302-12	76282030212	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12)Marketed from Dec 1, 2022
76282-302-90	76282030290	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90)Marketed from Jan 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): Alfuzosin hydrochloride
Generic name (nonproprietary): alfuzosin hydrochloride
Active ingredients: Alfuzosin hydrochloride — 10 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Exelan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090284
Marketing start: Oct 2, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92daSPL ID 663c0846-dc2c-409f-9fe0-bf2901ff92daSPL set ID f075a897-7bef-4799-b7e2-7e051c461443RxCUI 861132UNII 75046A1XTNUPC 0376282302102, 0376282302010, 0376282302126
Pharmacologic class: 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

N476282030201 followed by a unit qualifier and the quantity

Package 76282-0302-01. 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, 2023.

Indications (excerpt from the label)

Alfuzosin hydrochloride tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets USP, is an alpha adrenergic antagonist, indicated for treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: Alfuzosin hydrochloride is not indicated for the treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride is not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride is not indicated for the treatment of hypertension. Alfuzosin hydrochloride is not indicated for use in the pediatric population.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090284

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

FDA NDC Directory listings under ANDA 090284
Product	Strength	Form · route	Labeler	Product NDC
Alfuzosin Hydrochloride extended releasealfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	TabletOral	Cipla USA Inc.	69097-844
Alfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	43353-945