What is NDC 43353-945?

43353-945 is the product NDC for Alfuzosin hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alfuzosin hydrochloride?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alfuzosin hydrochloride NDC 43353-945

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-945Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0945Add 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
43353-945-16	4335309451643353094516	6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-16)Marketed from May 22, 2014
43353-945-30	4335309453043353094530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-30)Marketed from Apr 2, 2015
43353-945-60	4335309456043353094560	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-60)Marketed from Apr 2, 2015

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
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 43353-945_15c875e9-bc9e-4d06-83f5-0cc5c6742302SPL ID 15c875e9-bc9e-4d06-83f5-0cc5c6742302SPL set ID 790fe381-4a83-402e-b6c0-2ecde9cac7a7RxCUI 861132UNII 75046A1XTN
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

N443353094516 followed by a unit qualifier and the quantity

Package 43353-0945-16. 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 Dec 19, 2017.

Indications (excerpt from the label)

Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride 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)

About NDC 43353-945

What is NDC 43353-945?: 43353-945 is the product NDC for Alfuzosin hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alfuzosin hydrochloride.
What is the active ingredient?: Alfuzosin hydrochloride.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alfuzosin hydrochloride?: 13 other product NDCs are listed under this name. See all Alfuzosin 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 Alfuzosin hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Alfuzosin Hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	84386-153	84386-0153-0184386-0153-0584386-0153-30+2 more
Alfuzosin Hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Apotex Corp.	60505-2850	60505-2850-09
Alfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-967	51655-0967-52
Alfuzosin Hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Northwind Health Company, LLC	51655-087	51655-0087-52
Alfuzosin Hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-432	51655-0432-52
Alfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-155	29300-0155-0129300-0155-1329300-0155-19
Alfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-9155	63629-9155-0163629-9155-0263629-9155-03+1 more
Alfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Exelan Pharmaceuticals Inc.	76282-302	76282-0302-0176282-0302-0576282-0302-10+2 more
Alfuzosin Hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Rising Pharma Holdings, Inc.	57237-114	57237-0114-0157237-0114-0557237-0114-90
Alfuzosin Hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-2578	71335-2578-0171335-2578-0271335-2578-03+2 more

All 14 Alfuzosin hydrochloride NDCs

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	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Exelan Pharmaceuticals Inc.	76282-302
Alfuzosin Hydrochloride extended releasealfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	TabletOral	Cipla USA Inc.	69097-844