NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2578Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2578Add 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 NDC11-digit (billing)PackageCopy
71335-2578-1713352578017133525780130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-1)Marketed from Feb 6, 2025
71335-2578-2713352578027133525780260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-2)Marketed from Feb 6, 2025
71335-2578-3713352578037133525780390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-3)Marketed from Feb 6, 2025
71335-2578-47133525780471335257804120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-4)Marketed from Feb 6, 2025
71335-2578-57133525780571335257805100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-5)Marketed from Feb 6, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated, Extended release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079060
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 71335-2578_7ce6f1ee-cf32-445d-a682-b01823587446SPL ID 7ce6f1ee-cf32-445d-a682-b01823587446SPL set ID 37e89394-af6e-4700-bfa8-2effba1a286bRxCUI 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

N471335257801 followed by a unit qualifier and the quantity

Package 71335-2578-01. 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 .

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2578

What is NDC 71335-2578?
71335-2578 is the product NDC for Alfuzosin Hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. It has 5 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-15384386-0153-0184386-0153-0584386-0153-30+2 more
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralApotex Corp.60505-285060505-2850-09
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-96751655-0967-52
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-08751655-0087-52
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-43251655-0432-52
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralUnichem Pharmaceuticals (USA), Inc.29300-15529300-0155-0129300-0155-1329300-0155-19
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-915563629-9155-0163629-9155-0263629-9155-03+1 more
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC43353-94543353-0945-1643353-0945-3043353-0945-60
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralExelan Pharmaceuticals Inc.76282-30276282-0302-0176282-0302-0576282-0302-10+2 more
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralRising Pharma Holdings, Inc.57237-11457237-0114-0157237-0114-0557237-0114-90

All 14 Alfuzosin Hydrochloride NDCs

Other NDCs under ANDA 079060

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

FDA NDC Directory listings under ANDA 079060
ProductStrengthForm · routeLabelerProduct NDC
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-087
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralRising Pharma Holdings, Inc.57237-114
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-153

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in