NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2146Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2146Add 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
71335-2146-1713352146017133521460130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-1)Marketed from Apr 3, 2024
71335-2146-2713352146027133521460260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-2)Marketed from Apr 3, 2024
71335-2146-3713352146037133521460390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-3)Marketed from Jan 30, 2023
71335-2146-47133521460471335214604120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-4)Marketed from Apr 3, 2024
71335-2146-57133521460571335214605100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-5)Marketed from Apr 3, 2024

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, 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 079057
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 71335-2146_20858b72-0778-46d6-be98-37d913c425b0SPL ID 20858b72-0778-46d6-be98-37d913c425b0SPL set ID 98fa10c2-7c12-44aa-9112-e2fd6fa71d06RxCUI 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

N471335214601 followed by a unit qualifier and the quantity

Package 71335-2146-01. 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 is 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 tabletsare not indicated for the treatment of hypertension. Alfuzosin hydrochlori…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2146

What is NDC 71335-2146?
71335-2146 is the product NDC for Alfuzosin Hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, 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 079057

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

FDA NDC Directory listings under ANDA 079057
ProductStrengthForm · routeLabelerProduct NDC
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc.47335-956
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-432
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1449

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